ASSURED- hydrocortisone cream

Assured by

Drug Labeling and Warnings

Assured by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutic Al Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Hydrocortisone 1%

PURPOSE

Purpose

Anti-itch

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.

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.

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

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

help or contract a Poison Control Center right away.

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

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: ask a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients aloe barbadensis leaf juice, cetyl alcohol,

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED 
hydrocortisone cream

Product 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 not final	part348	05/25/2018

Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)