Otc - Active Ingredient
Active ingredient PurposeDiphenhydramine hydrochloride 2%...................Topical AnalgesicZinc acetate....................................................Skin protectant
Cvs Extra Strength Itch Relief
FDA Label NDC 59779-053
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Extra Strength Itch Relief (NDC 59779-053). 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.
Label Section Quick Index
Otc - Purpose
Uses- for the temporary relief of itching and pain associated with:-insect bites - minor burns - sunburn - minor skin irritations - minor cuts - scrapes- rashes due to poison ivy, poison oak, and poison sumac- 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
Uses- for the temporary relief of itching and pain associated with:
-insect bites - minor burns - sunburn - minor skin irritations - minor cuts - scrapes
- rashes due to poison ivy, poison oak, and poison sumac
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
Warnings
Warnings For external use onlyDo not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouthAsk a doctor before use on chicken pox or 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, or symptoms persist for ore 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 adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctorchildren under 2 years of age: consult a doctorOther information- store at 20 degrees - 25 degrees C (68 to 70 degrees F) - Lot No. and Exp. Date, see crimp of tube or see box
Inactive Ingredient
Inactive Ingredientscetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water
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