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:

  • insect bites
  • eczema
  • psoriasis
  • soaps
  • detergents
  • cosmetics,
  • jewelry,
  • poison oak,
  • poison sumac
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.

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

  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • Do no use for diaper rash. Consult a doctor.

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

  • Shake will before using.
  • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
  • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

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

carton

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 CARTON03/21/2019
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 finalpart34803/21/201905/01/2021
Labeler - AKRON PHARMA INC (067878881)
Establishment
NameAddressID/FEIBusiness Operations
SLV PHARMACEUTICALS LLC081225162manufacture(71399-0120)

Revised: 5/2021
 
AKRON PHARMA INC