Active Ingredients (In Each Packet)
Hydrocortisone acetate 1%
Anti-itch Cream
FDA Label NDC 82940-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shares Inc for the product Anti-itch Cream (NDC 82940-220). 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 packet), 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
anti-itch cream
Uses
temporarily relieves itching associated with minor skin irritations and rashes due to:
- eczema
- insect bites
- poison ivy, oak, or sumac
- soaps, detergents, or cosmetics
- jewelry
Warnings
for external use only
Do Not Use
- with any other hydrocortisone product unless you have consulted a doctor
- for the treatment of diaper rash, consult a doctor
When Using This Product
avoid contact with eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days
- symptoms 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 2 years and over - apply to affected area not more than 3 to 4 times daily
children under 2 years - do not use
Other Information
- do not use if package is torn, cut or opened
- store at room tempreature (do not freeze)
- see packet for Lot Number and expiration date
Inactive Ingredients
cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine
Questions
1-877-973-2811 Monday - Friday 8:00 AM to 5:00 PM
Package Label.Principal Display Panel
Hydrocortisone
1% hydrocortisone anti-itch cream
Net wt per pkt 1/32 oz (0.9 g)
20 pkts per box
* Please review the disclaimer below.
