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Maximum Strength Hydrocortisone Cream with Aloe

Medically reviewed on June 11, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 1.02g in 100g
Labeler: Walgreens
NDC Code: 0363-0620

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.

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: 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

for external feminine itching 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 the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, 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 occur again in a few days, rectal bleeding occurs, consult doctor promptly

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 * apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age * do not use, consult a doctor.

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 applicaion of this product.

Children under 12 years of age: consult a doctor.

Other information

Storage temperature: not to exceed 30oC (86oF).  Protect from freezing.

Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH. 

Carton Label

Tube Label

MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE 
hydrocortisone cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0620
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1.02 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER79.18 g  in 100 g
GLYCERIN1 g  in 100 g
CETOSTEARYL ALCOHOL7 g  in 100 g
CETYL PALMITATE4 g  in 100 g
ISOSTEARYL NEOPENTANOATE0.5 g  in 100 g
METHYLPARABEN0.2 g  in 100 g
ISOPROPYL MYRISTATE1.5 g  in 100 g
PEG-40 STEARATE0.5 g  in 100 g
BENZYL ALCOHOL1 g  in 100 g
POLYOXYL 20 CETOSTEARYL ETHER4 g  in 100 g
ALOE VERA LEAF0.1 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0620-031 TUBE in 1 CARTON
1NDC:0363-0620-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/07/2016
Labeler - Walgreens (008965063)
Establishment
NameAddressID/FEIOperations
Unipack, Inc.009248480manufacture(0363-0620)

 
Walgreens

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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