HYDROCORTISONE- hydrocortisone 1% cream 
Pharmacy Value Alliance LLC

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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Premier Value Hydrocortisone Cream 1%

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Keep out of 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 irritataions, inflammation and rashes due to

Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For External Use Only

Do not use

When using this Product

Stop Using this product and ask a doctor if

Directions

Adults and children 2 years and older

Children under 2 years of age

For External and Anal Itching

Other Information

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

Inactive Ingredients

Cetyl alcohol, Edetate disodium, Glyceryl monostearate, Methylparaben, Mineral oil, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, Sorbitan monostearate

Questions

Call 1-866-923-4914

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Other Information

This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10® Aloe

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

Product of PRC

Packaging

pv hydrocortisone cream 1oz PV03639

HYDROCORTISONE 
hydrocortisone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-149
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
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-149-011 in 1 BOX01/09/2020
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 not finalpart34801/09/2020
Labeler - Pharmacy Value Alliance LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 5/2023
Document Id: fb4547d7-628e-b4b5-e053-6294a90a7507
Set id: ab95e606-69f0-1d58-e053-2a95a90a073b
Version: 2
Effective Time: 20230509
 
Pharmacy Value Alliance LLC