Control Menstrual Cramp Relief

Description

KRT Control Cramp Cream is a topical formulation intended for the relief of muscle cramps and spasms. The active ingredient is menthol. This cream is packaged in a 3 oz (85 g) tube. Inactive ingredients include aloe vera gel, carbomer, glycerin, isopropyl myristate, propylene glycol, purified water, sodium hydroxide, and triethanolamine. The cream exhibits a light green color and possesses a minty fragrance.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children over 12 years of age, the recommended application involves applying the product directly to the affected area. The area should be massaged gently until the formulation is thoroughly absorbed into the skin. This process may be repeated as necessary, with a maximum frequency of four times daily.

For children aged 12 years or younger, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. The product should be kept out of reach of children; if ingested, immediate medical assistance or contact with Poison Control Center is required.

Discontinue use and consult a physician if the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, if redness or irritation occurs, medical advice should be sought.

Contact with eyes or mucous membranes should be avoided, and the product must not be applied to wounds or damaged skin.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion or misuse.

In cases where patients are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use. This precaution helps to ensure the safety of both the patient and the child.

Healthcare providers should emphasize the importance of keeping the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops. These signs may indicate a need for reevaluation of the treatment plan.

In the case of accidental swallowing, it is critical to seek emergency medical help or contact the Poison Control Center immediately to ensure appropriate management and care.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, if redness is present or irritation develops, medical advice should be sought.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Control Menstrual Cramp Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, even in the absence of documented overdosage effects. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of an overdose, the recommended actions include contacting a poison control center or seeking immediate medical attention. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

Healthcare professionals should remain vigilant and consider the possibility of interactions with other medications or underlying health conditions that may exacerbate the effects of an overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this product. It is important to emphasize the necessity of keeping the product out of reach of children. Patients should be informed that if the product is swallowed, they must seek medical help or contact the Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should stop using the product and seek medical advice if they notice any redness or if irritation develops.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and they should not apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the product's quality, the tube must be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not utilized within a specified time frame.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years, it should be applied to the affected area and massaged into the skin until fully absorbed, with a maximum frequency of four times daily as needed. For children aged 12 years or younger, it is advised to consult a doctor before use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Control Menstrual Cramp Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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