Analgesic

Description

Ou! Wee! is a jellyfish sting relief spray indicated for the alleviation of pain associated with jellyfish stings. It is the #1 recommended product for this purpose. The product is available in a dosage form of 4 fluid ounces (118 milliliters). The National Drug Code (NDC) for this formulation is 76417-8200-1.

Uses and Indications

This drug is indicated for the temporary relief of jellyfish stings.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be shaken well before use. It is to be applied to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to salicylates, including aspirin, should avoid use due to the risk of allergic reactions.

• Application to open wounds or damaged skin is prohibited to prevent exacerbation of the condition.

• Tight bandaging of the area where the product is applied is not recommended, as it may lead to increased irritation or adverse effects.

• If excessive skin irritation occurs, or if the condition worsens, persists for more than 7 days, or recurs shortly after improvement, discontinue use and consult a healthcare professional.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from open flames and other sources of ignition.

To ensure safety, this product must be stored out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or a poison center should be contacted without delay.

Care should be taken to avoid contact with the eyes. The product should not be applied to open wounds or damaged skin, and it is advised not to bandage the area tightly after application.

Healthcare professionals should advise patients to consult a physician if excessive skin irritation occurs or if there is a known history of allergic reactions to salicylates, including aspirin.

If the condition being treated worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days, the use of this product should be discontinued, and a healthcare provider should be consulted for further evaluation and management.

Side Effects

Patients should be aware of several important warnings and adverse reactions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from flames. Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or a poison center should be contacted.

Patients are advised to avoid contact with the eyes and to refrain from applying the product to open wounds or damaged skin. Bandaging should not be done tightly over the area of application. If excessive skin irritation occurs, or if the patient has a history of allergic reactions to salicylates, including aspirin, consultation with a healthcare provider is recommended.

In clinical observations, if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of the product and seek medical advice.

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 Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking well and applying it to the affected area no more than 3-4 times daily. For infants and children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a poison control center for guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers assess the situation thoroughly and initiate appropriate management procedures based on the severity of the symptoms presented.

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 keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison center immediately.

Patients should be cautioned to avoid contact with their eyes, as this may lead to irritation. It is important to inform patients not to apply the product to open wounds or damaged skin, and to avoid tight bandaging of the area where the product is applied.

Healthcare providers should encourage patients to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, patients should be informed that if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and seek medical advice.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically for both adults and children aged 2 years and older. Patients are advised to shake the product well before application and to apply it to the affected area no more than 3 to 4 times daily.

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 Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)