FDA Label for Quality Choice Itch Relief
View Indications, Usage & Precautions
Quality Choice Itch Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc.. 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.
Otc - Active Ingredient
Active ingredient Purpose
Hydrocortisone 1%..................................................Anti-itch
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
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