HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
Walgreen Company

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 Cream, USP 1% with Aloe

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children. 

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

Directions

Adults and children 2 years of age and older

Children under 2 years of age

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other Information

Inactive Ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

Well at Walgreens

MAXIMUM STRENGTH
Hydrocortisone Cream, USP 1% with Aloe
Anti-Itch Cream

For the temporary relief of itches & rashes due to:
 

• Insect bites
• Eczema
• Poison ivy, oak, sumac
• Seborrheic dermatitis
• External genital, feminine & anal itching
• Psoriasis
• Detergents, jewelry & cosmetics

Compare to Cortizone•10® Active Ingredient‡‡
Relieves itches & rashes
NET WT 1 OZ (28 g)

03390311B1             VC110440

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HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0339
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
May containSODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0339-561 in 1 CARTON07/16/201001/31/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0363-0339-571 in 1 CARTON07/16/2010
256 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 FINALpart34807/16/2010
Labeler - Walgreen Company (008965063)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017
Document Id: b1bb33a3-b7d1-4702-981e-38fc2b02121f
Set id: 593eb461-e58b-4457-9bc3-b1ea44d3c5de
Version: 5
Effective Time: 20171222
 
Walgreen Company