Label: ASSURED- hydrocortisone cream
- NDC Code(s): 55621-018-28
- Packager: Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
•temporarily relieves itching ssociated with minor skin
irritation, inflammation and rashesdue to:
•eczema •psoriasis •poison ivy, oak, sumac
•insect bites •detergents •jewelry
•cosmetics •soaps •seborrheic dermatitis
•temporarily relieves external anal and genital itching
•other uses of this product should be under advice and
supervision of a doctor
-
WARNINGS
. Warnings. For external use only
•in the genital area if you have a vaginal Do not use
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 relieving 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
• s: for external anal and genital itching, adult
•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: ask a doctor
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
aloe barbadensis leaf juice, cetyl alcohol, Inactive ingredients
dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate,
isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum,
phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic
acid, tocopherol, water, zingiber officinale (ginger) root extract
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASSURED
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55621-018 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) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) EDETIC ACID (UNII: 9G34HU7RV0) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOHEXADECANE (UNII: 918X1OUF1E) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYL GLUCETH-20 (UNII: J3QD0LD11P) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) GINGER (UNII: C5529G5JPQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55621-018-28 1 in 1 CARTON 05/25/2018 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 05/25/2018 Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)