HYDROCORTISONE 1%- hydrocortisone cream 
Trifecta Pharmaceuticals Usa Llc

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Best Choice Hydrocortisone Cream 1% Anti-Itch Cream

DRUG FACTS

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps

● detergents ● cosmetics ● jewelry ● external feminine genital 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:

For the treatment of a diaper rash, consult with doctor

For external genital itching if you have a vaginal discharge, consult doctor

When using this product

Stop using this product and ask a doctor if

Directions

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a doctor.

For External and anal itching:

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.

Children: under 12 years of age with external anal itching: consult a doctor.

Inactive ingredients

Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral oil, Mono-di glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

Other information

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

Questions

Call 1-800-883-0085

Distributed By

Proudly Distributed by:

Associated Wholesale Grocers, Inc.

Kansas City, Kansas 66106

For product information please visit:

bestchoicebrand.com/62229

*Cortizone 10 ® is a registered trademark of Sonafi Inc.

Best Choice Hydrocortisone Cream 1oz 050923 CDER

HYDROCORTISONE 1% 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-129
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MINERAL OIL (UNII: T5L8T28FGP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-129-011 in 1 BOX11/16/2023
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01611/10/2023
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 9/2023
Document Id: 0a59f129-9e48-0c01-e063-6394a90a74f9
Set id: 0a5a35be-9e21-18dd-e063-6394a90a097f
Version: 1
Effective Time: 20230927
 
Trifecta Pharmaceuticals Usa Llc