TRIMAZOLE- clotrimazole cream 
Trifluent Pharma LLC

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Trimazole™

Drug Facts

Active ingredient

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

Ask a doctor before use if you are using any other medicines or cleansers on your skin.

When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch).

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Other information

Store at 15-30°C (59-86°F). Avoid excessive heat.

Do not use if product is damaged.

Inactive ingredients

Aloe barbadensis leaf extract, aminomethyl propanol, caprylic / capric triglyceride, cetyl alcohol, disodium EDTA, glyceryl stearate, hydroxypropylcellulose, Lavandula angustifolia (lavender) oil, Melaleuca alternifolia (tea tree) oil, methylparaben, PEG 100 stearate, polyethylene glycol 400, polysorbate 20, polysorbate 60, propylene glycol, propylparaben, purified water, stearic acid.

Questions/Comments?

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label

Tear at notch to open. Do not use if seal is broken.

NDC 73352-570-01

TRIFLUENT
PHARMA™

Trimazole™

1% Clotrimazole

Topical Antifungal Cream

NET WT. 3 OZ. (85 G)

PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label
TRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-570
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73352-570-011 in 1 POUCH06/10/2024
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM00506/10/2024
Labeler - Trifluent Pharma LLC (117167281)

Revised: 6/2024
Document Id: 0d1bbd89-93bb-4c6e-9253-b48746977d19
Set id: a3bafc52-1404-4e0b-84c1-e28bffcb091e
Version: 1
Effective Time: 20240611
 
Trifluent Pharma LLC