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Hydrocortisone with Aloe Maximum Strength

Medically reviewed on June 14, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: NuCare Pharmaceuticals, Inc.
NDC Code: 68071-3197

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.

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH

Drug Facts

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 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 application of this product
Children under 12 years of age: consult a doctor

Other information
  • Store at room temperature 59°-86°F (15°-30°C).Protect from freezing.
  • Before using any medication, read all label directions.Keep carton, it contains important 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

HYDROCORTISONE WITH ALOE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3197(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 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
POLYOXYL 40 STEARATE 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBIC ACID 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WHITE WAX 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE 
Packaging
#Item CodePackage Description
1NDC:68071-3197-11 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/1998
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCare Pharmaceuticals, Inc.010632300relabel(68071-3197)

 
NuCare Pharmaceuticals, Inc.

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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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