HYDROCORTISONE- hydrocortisone acetate cream 
Blossom Pharmaceuticals

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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Blossom Pharmaceuticals Hydrocortisone Cream 1%

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

For temporary relief of;

Itching and rashes due to;

and for external itching of;

Do not use:

Stop use and ask a physician if:

Keep out of reach of children

Dosage & Administration:

Adults and children over 2 years of age
Children under 2 years of age
Adults

Other information:

Inactive ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Sodium Betabisulphite, White Soft Paraffin, Water (purified)

For temporary relief of minor skin irritations and external itching.

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Blossom Pharmaceuticals Hydrocortisone 1%

Hydrocortisone.jpg

Hydrocortisone

HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61767-224-0172 in 1 CASE
128.3 g in 1 TUBE
2NDC:61767-224-0412 in 1 CASE
2425 g in 1 JAR
3NDC:61767-224-0212 in 1 CASE
3144 in 1 BOX
30.9 g in 1 PACKET
4NDC:61767-224-031728 in 1 CASE
40.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2014
Labeler - Blossom Pharmaceuticals (677381470)

Revised: 5/2014
Document Id: 49f52e32-fdeb-43c5-a341-008d64a43514
Set id: 06c36832-af0d-4dbc-88cf-3434fa1cfe5c
Version: 1
Effective Time: 20140515
 
Blossom Pharmaceuticals