FAMILY WELLNESS- hydrocortisone 1% cream 
FRONT PHARMACEUTICAL PLC

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Active ingredients

Hydrocortisone 1%

Purpose

Anti-itch

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  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

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

help or contact a Poison Control Center right away.

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

Other information

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

aloe barbadensis leaf juice, Inactive ingredients

ceteastrearyl alcohol, edetate disodium, glyceryl

monostearate, methylparaben, mineral oil, polysorbate

60, propylene glycol, span 60, water, white petrolatum

1-800-638-3800  Weekdays 0 AM to 4 PM EST Questions? 

image description

FAMILY WELLNESS 
hydrocortisone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-009
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69571-009-011 in 1 CARTON06/18/2017
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 DrugM01706/18/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIBusiness Operations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-009)

Revised: 10/2023
Document Id: 08ad6eaa-df8b-8f2e-e063-6394a90a16b0
Set id: ea26265d-f24e-458e-8bf0-287b2d49f4f4
Version: 2
Effective Time: 20231027
 
FRONT PHARMACEUTICAL PLC