FDA Label for Itch Relief
View Indications, Usage & Precautions
Itch Relief Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Hydrocortisone 1%
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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