ASTONEA- hydrocortisone cream 
ASTONEA LABS PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ASTONEA Hydrocortisone

Active Ingredient

Hydrocortisone Acetate USP (1% w/w)

Purpose

Anti-itch

Uses

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

Ask a doctor before use

■ if you are pregnant or breast feeding

Stop use and ask a doctor if

■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ adults and children over 2 years of age

■ apply evenly to affected area no more than 3 to 4 times daily

■ children under 2 years of age■ do not use, consult a doctor

Adults

■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying

■ apply externally to the area up to 6 times a daily or after a bowel movement

■ after application discard pad

■ do not flush in toilet

Other information

■ store at 20-25C (68-77F) 

■ avoid excessive heat and humidity

Inactive Ingredients

cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Package Label

Principal Display and Drug Fact Panel

ASTONEA 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
CETETH-20 (UNII: I835H2IHHX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-305-020.9 g in 1 PACKET; Type 0: Not a Combination Product05/02/2022
2NDC:77338-305-0328.3 g in 1 TUBE; Type 0: Not a Combination Product05/02/2022
3NDC:77338-305-06454 g in 1 JAR; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/02/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-305)

Revised: 9/2022
Document Id: e81a1b4e-5084-2550-e053-2995a90a9bff
Set id: de09e859-c5fd-0cc5-e053-2a95a90a147e
Version: 3
Effective Time: 20220907
 
ASTONEA LABS PRIVATE LIMITED