Your browser does not support JavaScript! WALGREENS HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [WALGREEN COMPANY]
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WALGREENS HYDROCORTISONE PLUS 12 MOISTURIZERS (hydrocortisone) cream
[Walgreen Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

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

Directions

  • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor

Other information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • Store at 20° to 25° C (68° to 77° F)
  • See carton or tube crimp for lot number and expiration date

Inactive Ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

Questions?

Call 1-866-923-4914

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

MAXIMUM STRENGTH

Hydrocortisone Cream 1%
Plus 12 Moisturizers
Anti-Itch Cream Enriched With Vitamins

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
WALGREENS   HYDROCORTISONE PLUS 12 MOISTURIZERS
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-2063
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
cetostearyl alcohol 
sodium lauryl sulfate 
sodium cetostearyl sulfate 
chamomile flower oil 
citric acid monohydrate 
corn oil 
glycerin 
glyceryl monostearate 
isopropyl palmitate 
maltodextrin 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylene glycol 
propylparaben 
water 
stearyl alcohol 
Vitamin A palmitate 
cholecalciferol 
.alpha.-tocopherol acetate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-2063-021 in 1 CARTON
128.4 g in 1 TUBE
2NDC:0363-2063-061 in 1 CARTON
245 g in 1 TUBE
3NDC:0363-2063-031 in 1 CARTON
360 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/03/1989
Labeler - Walgreen Company (008965063)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(0363-2063)

Revised: 6/2014
 
Walgreen Company

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