The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs (NDC 59779-248). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient PurposeDiphenhydramine HCL 2% ...................................................................Topical analgesicZinc Acetate 0.1%...............................................................................Skin Protectant
Otc - Purpose
UsesTemporarily relieves itching and pain associated with minor irritations, burns,scrapes, cuts, insect bites and rashes due to poison ivy, poison oak and poisonsumac. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
UsesTemporarily relieves itching and pain associated with minor irritations, burns,scrapes, cuts, insect bites and rashes due to poison ivy, poison oak and poisonsumac. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Warnings
Warnings For external use only. Flammable. keep away from fire or flame.Do not use - with any other product containing diphenhydramine, even one taken by mouth. - On large areas of the bodyAsk a doctor before use - on chicken pox - on measlesWhen using this product avoid contact with the eyesStop use and ask a doctor if condition worsens or does not improve within 7 days.- symptoms persist for more than 7 days or clear up and occur again within a few days.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions- do not use more than directed- Adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily- Children under 2 years of age: consult a doctorOther informationStore at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredient
Inactive Ingredientspurified water, SD alcohol 40-B, glycerin, povidone, tromethamine
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