Otc - Active Ingredient
Active ingredient PurposeDiphenhydramine HCL 2% ...................................................................Topical analgesic
Cvs
FDA Label NDC 59779-048
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 (NDC 59779-048). 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
UsesTemporarily relieves pain and itching associated with- minor burns - insect bites - sunburn - minor skin irritations- minor cuts - scrapes - rashes due to 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 pain and itching associated with- minor burns - insect bites - sunburn - minor skin irritations- minor cuts - scrapes - rashes due to poison ivy, poison oak and poison sumac
Warnings
Warnings For external use onlyDo not use - on large areas of the body - with any other product containing diphenhydramine, even one taken by mouthAsk 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 if the 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: ask 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, propylene glycol, diazolidinyl urea, hydroxypropyl methylcellolose, camphor, methylparaben, citric acid, sodium citrate, propylparaben
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