DERMATIN ANTIFUNGAL- clotrimazole cream

Dermatin by

Drug Labeling and Warnings

Dermatin by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 accompanying these conditions
  

WARNINGS

Warnings
For external use only

• When using this product avoid contact with the eyes
  

DO NOT USE

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

STOP USE

Stop use and ask a doctor if

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• clean the affected area and dry thoroughly
• apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
• children under 12 years of age should be supervised in the use of this product
• for athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes: change shoes and socks at least once daily
• for athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
• this product is not effective on scalp or nails
  

INACTIVE INGREDIENT

Other ingredients  Water, T36 C5 Melaleuca Oil, Stearic Acid, Cetyl alcohol, SD Alcohol 40B, Glyceryl Stearate and PEG 100 Stearate, Steareth 21, Propylene Glycol, Dimethicone, Acrylates/C10-30 Alkylacrylates Crosspolymer, Triethanolamine, Steareth 2, Benzyl Alcohol, Methylsothiazolinone, BHT.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATIN  ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALCOHOL (UNII: 3K9958V90M)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-096-01	14 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2012

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		079711683	manufacture(54473-096)