HYDROCORTISONE- hydrocortisone lotion 
AKRON PHARMA INC

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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Hydrocortisone USP 1% Lotion



Drug Facts

Active Ingredient

Hydrocortisone 1% (Micronized)

Purpose

Antipruritic (Anti-itch)

Use

For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

Warnings

For external use only.

When using this product

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

Keep out of Reach of Children

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

Directions

Other Information

• Store away from excessive heat or cold.  Shake well before using.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

Questions?

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

Rev. 03/19

Manufactured in U.S.A

lotion

HYDROCORTISONE 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-0120-11 in 1 CARTON05/17/2021
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/17/2021
Labeler - AKRON PHARMA INC (067878881)

Revised: 3/2023
Document Id: 30b86201-aa2c-44df-b1ac-bc7009f5a1d0
Set id: daad9a1e-98d2-4ce7-9d97-ac5d81905abb
Version: 5
Effective Time: 20230310
 
AKRON PHARMA INC