HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
Actavis Mid Atlantic 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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ACTIVE INGREDIENT

Hydrocortisone 1%

PURPOSE

Anti-itch

USES

For the temporary relief of itching due to minor skin irritations, inflammation, and rashes from:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external genital, feminine 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

  • in the eyes
  • for external feminine itching if you have a vaginal discharge
  • for the treatment of diaper rash

WHEN USING THIS PRODUCT

  • do not begin the use of any other hydrocortisone product
  • for external anal itching:
  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK A DOCTOR IF

  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and come back in a few days
  • rectal bleeding occurs, consult promptly

KEEP OUT OF REACH OF CHILDREN.

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

DIRECTIONS

For general use

  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times a day
  • children under 2 years: do not use, ask a doctor

For external anal itching

  • adults and children 12 years and older: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product
  • children under 12 years: ask a doctor

INACTIVE INGREDIENTS

Aloe vera concentrate, cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, and white wax.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Actavis

NDC 0472-0339-56

Anti-itch Cream

Hydrocortisone CREAM USP 1% WITH ALOE

Compare to the active ingredient in Cortaid® Maximum Strength Cream*

MAXIMUM STRENGTH

Maximum Strength Formula for Temporary Relief of Itching Associated with Irritations, Inflammations and Rashes Due to:

  • Poison Ivy, Oak, Sumac
  • Eczema
  • Insect Bites
  • Seborrheic Dermatitis
  • External Genital or Anal Itch

NET WT 1 OZ (28 g)

03390203E1 VC106541

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CARTON LABEL

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0339
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WHITE WAX 
POLYOXYL 40 STEARATE 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:0472-0339-561 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/1998
Labeler - Actavis Mid Atlantic LLC (809515898)

Revised: 03/2012
 
Actavis Mid Atlantic LLC