DERMATIN ANTIFUNGAL- clotrimazole cream 
Melaleuca, Inc.

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.

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Dermatin Antifungal

Active ingredients
Clotrimazole 1%

Purpose
Antifungal

Uses

Warnings
For external use only

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

Stop use and ask a doctor if

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

Directions

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.

DermatinPeelaway

DERMATIN  ANTIFUNGAL
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-096
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-096-0114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2012
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-096)

Revised: 1/2023
Document Id: f205b04d-16d4-02ba-e053-2a95a90a0108
Set id: e993fa3b-1d85-46b7-bda5-ed875be74c4e
Version: 6
Effective Time: 20230111
 
Melaleuca, Inc.