Active Ingredients (In Each Gram)
Diphenhydramine HCl 2%
Zinc acetate 0.1%
Allergic Itch Relief
FDA Label NDC 63941-316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers, Co. for the product Allergic Itch Relief (NDC 63941-316). 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 active ingredients (in each gram), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Skin protectant
Uses
- temporarily relieves itching and pain associated with insect bites, minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
- dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Warnings
For external use only
Do Not Use
- on chicken pox or measles
- with any other product containing diphenhydramine, even one taken by mouth
- on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin
When Using This Product
- avoid contact with eyes
Stop 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.
Directions
- adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
- do not use more often than directed
Other Information
- store at 59° to 77°F
Inactive Ingredients
carbomer 940, cetyl alcohol, glycerin, glyceryl monostearate, light liquid paraffin, methylparaben, polysorbate 60, propylparaben, purified water, and stearic acid
Package Label
Anti-Itch Cream
* Please review the disclaimer below.
