ATOPALM CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream

ATOPALM CLOTRIMAZOLE ANTIFUNGAL by

Drug Labeling and Warnings

ATOPALM CLOTRIMAZOLE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

Clotrimazole 1%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings       For external use only.

Do not use on diaper rash or on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch).
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
• supervise children in the use of this product
• for athlete's foot, pay special attention to spaces between toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day.
• for athlete's foot and ringworm, use daily for 4 weeks, for jock itch use daily for 2 weeks
• if condition persists longer, ask a doctor
• this product not effective on the scalp or nails
  

STORAGE AND HANDLING

Other Information

• store at 20 degrees to 25 degrees  (68 degrees to 77 degrees F)
• see end of carton or tube crimp for lot number and expiration date
  

INACTIVE INGREDIENT

Inactive Ingredients

Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine

QUESTIONS

Questions? Call 1-855-ATOPALM

SPL UNCLASSIFIED SECTION

US Patent US 6221371B1

Distributed by: NeoPharm Co., Ltd, 80 Wood Rd, 212 Camarillo, CA 93010

Made in Korea

SPL UNCLASSIFIED SECTION

Clotrimazole 1%
Antifungal
Cream

Product Labeling

INGREDIENTS AND APPEARANCE

ATOPALM CLOTRIMAZOLE ANTIFUNGAL  
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-1000-1	1 in 1 CARTON
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/16/2011

Labeler - NeoPharm Co., Ltd. (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-1000)