ASSURED- hydrocortisone cream 
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.

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Active ingredients

Hydrocortisone 1%

Purpose

Anti-itch

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. 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.

. If swallowed, get medical Keep out of reach of children

help or contract a Poison Control Center right away.

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

Other information

•store at room temperature 68° - 77° F (20° - 25° C)

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

1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

image description

ASSURED 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55621-018-281 in 1 CARTON05/25/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/25/2018
Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)

Revised: 10/2023
Document Id: 08846c1b-91dd-aadf-e063-6294a90accfa
Set id: bc97f364-9443-47b8-9c2d-b5dcc00cc9b7
Version: 6
Effective Time: 20231025
 
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.