OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM- clotrimazole aerosol, foam 
Prime Packaging, 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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PRINCIPAL DISPLAY PANEL - 125g Can Label

PRINCIPAL DISPLAY PANEL - 177mL Can Label

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet

Helps support

skin barrier function

NET WT. 4.4 OZ (125g)

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.

When using this product: • Avoid contact with the eyes.

• Do not use on deep or puncture wounds, infections or lacerations.

Stop use and ask a doctor if

• Irritation occurs or if there is no improvement wihin 4 weeks.

Contents under pressure. Protect from heat and direct sunlight. Do not puncture or incinerate. Do not store at temperatures above 120°F.
If pregnant or breast feeding, ask a health professional before use. 

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

Inactive Ingredients Water, Cetearyl ethylhexanoate, Propylene, glycol, Butane, Palmitic acid, Stearic acid, Propane, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl acetate, Disodium EDTA, Ubiquinone

Questions or comments? Call toll free 1-855-317-1107

OCCULUS  SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM
clotrimazole aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PALMITIC ACID (UNII: 2V16EO95H1)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
UBIDECARENONE (UNII: EJ27X76M46)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0090-3125 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/2015
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0090) , pack(13630-0090)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0090)

Revised: 6/2015
Document Id: 7db423a6-edb6-4998-99c5-e697a9a993b8
Set id: a91d077f-8f9e-48fd-8554-0428bdfe1eb7
Version: 1
Effective Time: 20150615
 
Prime Packaging, Inc.