NDC | 63868-594-28 |
Set ID | a47b4b0b-e78d-43b2-bc70-a4777186ab63 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
-
PURPOSE
Uses
- for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
- for temporary relief of external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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: consult 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 soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients
aloe vera gel ascorbic acid, butylated hydroxytoluene, cetanol chamomile oil, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, retinol palmitate oil, sodium hydroxide, sorbitan monostearate, stearyl alcohol, tocopheryl acetate
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-594 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBIC ACID (UNII: PQ6CK8PD0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-594-28 1 in 1 CARTON 01/20/2015 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/19/2015 Labeler - Chain Drug Marketing Association Inc (011920774)