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Anti-itch by Medline Industries, Inc.

Medically reviewed on September 25, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Medline Industries, Inc.
NDC Code: 53329-091

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.

Drug Facts

Active ingredient (in each gram)

Hydrocortisone USP 10mg

Purpose

Antipuritic (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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
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

Do not use
for the treatment of diaper rash
with any other Hydrocortisone product unless you have consulted a doctor

Consult a doctor
before use if you have a vaginal discharge (for external feminine itching)
for external itching, do not exceed the recommended daily dosage or if bleeding occurs
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product
avoid contact with eyes
do not put this product into rectum by using fingers or any mechanical device or applicator

Keep out of reach of children.

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

Directions
For 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
Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children under 12 years of age: for external anal itching, consult a doctor.

Other information
Protect from freezing. Avoid excessive heat.
Do not use if packet is torn, cut or opened.

Inactive ingredients

Citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

Package/Label Principal Display Panel

Curad Hydrocortisone Cream

Curad Hydrocortisone Cream

CURAD

WE HELP HEAL

Hospital Quality

Hydrocortisone Cream 1%

Latex Free Product

Net Wt. 1 oz (28.4g)

Hydrocortisone Cream 1%

1% Hydrocortisone Anti-Itch

NET WT. 1 oz (28.4 g)

ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-091
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
GLYCERYL STEARATE CITRATE 
METHYLPARABEN 
PETROLATUM 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:53329-091-011 TUBE in 1 BOX
128.4 g in 1 TUBE
2NDC:53329-091-9148 PACKET in 1 CARTON
2NDC:53329-091-901.5 g in 1 PACKET
3NDC:53329-091-96144 TUBE in 1 CASE
328.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2010
Labeler - Medline Industries, Inc. (025460908)

 
Medline Industries, 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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