OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1- 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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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 within 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. If product is swallowed, get medical help or contact a Poison Control Center right away. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

Inactive Ingredients

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

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

PRINCIPAL DISPLAY PANEL - 125 g Can Label

PRINCIPAL DISPLAY PANEL - 125g Can Label

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet


NET WT. 4.4 OZ (125g)

OCCULUS  SKIN HYDRATING TOPICAL FOAM CLO-1
clotrimazole aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0092
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)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
UBIDECARENONE (UNII: EJ27X76M46)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0092-3125 g in 1 CAN; Type 0: Not a Combination Product08/01/2015
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 Enterprises, Inc.101946028manufacture(13630-0092) , analysis(13630-0092)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0092) , pack(13630-0092)

Revised: 1/2020
Document Id: 9c5c6bcc-c2b7-7c8b-e053-2995a90ad7f0
Set id: 33e56295-4edc-43fd-a937-1eeb32414fdb
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.