ATHLETES FOOT ANTIFUNGAL ANTIFUNGAL- clotrimazole cream

Athletes Foot Antifungal by

Drug Labeling and Warnings

Athletes Foot Antifungal by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Anicare Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Drug Facts

Clotrimazole 1%

Purpose

Antifungal

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

• cures most athlete's foot
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor

When using this product avoid contact with the eyes

Stop use and consult a doctor if

• irritation occurs
• there is no improvement within 2 weeks

Directions

This product is not effective on the scalp or nails

• clean the affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor. Pay special attention between the toes. Wear well fitting, ventilated shoes and change shoes and socks at least once a day.
  
• supervise children in the use of this product
• use daily for 4 weeks
• if condition persists longer, ask a doctor
  

Other information

• store at temperature between 59° - 86° F  (15° - 30° C)
• do not use if seal on tube is punctured or missing

Inactive ingredients

bees wax, cetryl alcohol, disodium EDTA, glyceryl stearate, methyl paraben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propyl paraben, purified water, sorbitan tristerate, Sodium Hydroxide.

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Clotrimazole USP 1%

Athlete's Foot

Antifungal Cream

Cures most major types of athlete's foot

Relieves

•  Itching
• Burning
• Scaling
• Cracking
  

Greaseless

Odorless

Non-staining

NET WT. 1.25 OZ.  (35 g)

DRUGSTORE-Rx

SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India

INGREDIENTS AND APPEARANCE

ATHLETES FOOT ANTIFUNGAL  ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-2435
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	350 mg  in 35 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-2435-1	35 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/10/2013

Labeler - Personal Care Products, Inc. (966155082)

Registrant - Personal Care Products, Inc. (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd.		916837425	manufacture(29500-2435)