Label: FAMILY WELLNESS- hydrocortisone 1% cream
- NDC Code(s): 69571-009-01
- Packager: FRONT PHARMACEUTICAL PLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
•temporarily relieves itching associated with minor skin
irritations, inflammation and rashes due to:
•eczema •psoriasis •poison ivy, oak, sumac
•insect bites •detergents •jewelry
•cosmetics •soaps •saborrheiic dermatitis
•temproarily relieves external and genital itching
•other uses of this product should be under advice and
supervision of a doctor
-
WARNINGS
Warnings For external use only.
: Do not use
•in the genital area if you have vaginal discharge. Consult a doctor.
•for the treatment of diaper rash. Consult a doctor.
: When using this product
•avoid contact with 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 use and ask a doctor if
•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
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
•for itching or 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 and genital itching, adults:
•when practical, clean the affected area with mild soap
and warm waterand 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: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS
hydrocortisone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69571-009 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) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69571-009-01 1 in 1 CARTON 06/18/2017 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 Drug M017 06/18/2017 Labeler - FRONT PHARMACEUTICAL PLC (530897792) Establishment Name Address ID/FEI Business Operations FRONT PHARMACEUTICAL PLC 530897792 manufacture(69571-009)
