Medication Guide App

Formu Care Anti Itch maximum strength

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Access Business Group LLC
NDC Code: 10056-541

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.

Access Business Group International LLC Anti-Itch Cream 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
  • seborrheic dermatitis
  • soaps
  • external genital 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 the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product
  • avoid contact with the eyes
  • do not begin use of any other hydrocortisone product unless you have asked a doctor
  • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
  • do not put this product 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

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. Ask a doctor.

for external anal itching:

  • adults: when practical, cleanse 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 application of this product.
  • children under 12 years of age with external anal itching: ask a doctor

Other information
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Relieves Itching And Redness Fast!

Helps Heal Rashes For Healthier Skin

Maximum Strength Cream

Maximum Strength

Anti-Itch Cream

1% Hydrocortisone Anti-Itch Cream

Anti-Itch Cream Carton Image 1

Anti-Itch Cream Carton Image 2

FORMU CARE ANTI ITCH  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-541
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 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
CETYL PALMITATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
WATER 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10056-541-641 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/12/2009
Labeler - Access Business Group LLC (839830713)

Revised: 08/2009
 
Access Business Group LLC

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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