Active Ingredients
Diphenhydramine hydrochloride 1%
Zinc Acetate 0.1%
Anti-itch Cream
FDA Label NDC 80489-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ol Pharma Tech, Llc for the product Anti-itch (NDC 80489-005). 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, purpose, uses, warnings, ask a doctor before use, do not use, when using this product, stop use and ask a doctor if, 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, and poison sumac
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
Warnings
For external use only
Ask A Doctor Before Use
- on chicken pox
- on measles
Do Not Use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
When Using This Product
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
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.
Directions
Do not use more 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
- 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
do not use more than directed:
Other Safety Information
protect from excessive heat (40°C/104°F)
Inactive Ingredients
cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E
Questions
drspharmacyusa.com
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Itch stopping cream
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