Otc - Active Ingredient
Active ingredient Purpose
Hydrocortisone 1%..................................................Anti-itch
Quality Choice Itch Relief
FDA Label NDC 63868-603
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Quality Choice Itch Relief (NDC 63868-603). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Otc - Purpose
Uses
- temporarily relieves itching associated with minor skin irritation, inflammation, and rashed due to
- eczema
- psoriasis
- jewelry
- insect bites
- soaps
- cosmetics
- detergents
- seborrheic dermatitis
- poison ivy, oak sumac
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
- more than directed unless directed by a doctor
Otc - When Using
When using this product
- avoid contact with eyes
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
Stop use and ask a doctor
- condition worsens, 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- for itching of skin irritation, inflammation, and rashes:
- 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
- for external anal and genital itching, 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
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
butylated hydroxytoluene, cetostearyl alcohol, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monooleate, steareth-20, stearic acid
Dosage & Administration
Distributed by:
C.D.M.A., Inc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Made in China
* Please review the disclaimer below.
