Active Ingredients (In Each Gram)
Diphenhydramine HCl 2%
Zinc acetate 0.1%
Anti-itch
FDA Label NDC 67510-0633
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Anti-itch (NDC 67510-0633). 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 pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- 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 large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
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
- do not use more often than directed
- adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Other Information
- store at 20° - 25°C (68° - 77°F)
Inactive Ingredients
Carbomer 940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Methylparaben, Polysorbate 60, Propylparaben, Purified water, and Stearic acid
Questions Or Comments?
1-800-883-0085
Package Label
Anti-Itch Cream
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