Active Ingredient
Hydrocortisone 1%
Itch Relief Cream
FDA Label NDC 69396-057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Itch Relief (NDC 69396-057). 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 ingredient, purpose, keep out of reach of children, uses, warnings, when using this product, stop using this product and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Keep Out Of Reach Of Children
If Swallowed, get medical help or contact a Poison Control Center right away.
Uses
For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to
- Eczema
- Insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- sunburn
- temporarily relieves external anal and genital itching.
Other uses of this product should be only under the advice and supervision of a doctor
Warnings
For External Use Only
Do not use
- In the genital area if you have a vaginal discharge.
When Using This Product
- Avoid contact with the eyes.
- Do not use more than directed unless told to do so by a doctor.
- Do not put directly into rectum by using fingers or any mechanical device or applicator.
Stop Using This Product And Ask A Doctor If
- Conditions worsen
- Symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
- Rectal bleeding occurs.
Directions
For itching or skin irritations, inflammation, and rashes.
Adults and children 2 years and older
- Apply to affected area not more than 3 to 4 times daily.
- ask a doctor.
- Adults: When practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- Children under 12 years of age: ask a doctor
Children under 2 years of age
For External and Anal Itching
Other Information
Store at controlled room temperature 20°-25°C (68°-77°F)
This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10®
Distributed By:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI. 02895
Product of China V-36756
Inactive Ingredients
Aloe Barbadensis leaf juice, cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, Glycerin, Glyceryl stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2- Phenoxyethyl alcohol, Polysorbate 80, Propylene glycol, purified water, Stearic acid, Trisodium citrate dihydrate, Vitamin E.
Questions
Call 1-800- SHOP CVS
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