OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1- clotrimazole aerosol, foam

Occulus by

Drug Labeling and Warnings

Occulus by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
• For effective relief of redness, irritation, scaling, cracking, itching, burning feet.

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

• Hold can upright. Shake well before each application.
• Clean the affected area and dry thoroughly.
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
• For athlete's foot and ringworm, use daily for 4 weeks.
• If condition persists longer, consult a doctor.
• This product is not effective on the scalp or nails.

Inactive Ingredients

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

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PRINCIPAL DISPLAY PANEL - 125 g Can Label

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet

NET WT. 4.4 OZ (125g)

INGREDIENTS AND APPEARANCE

OCCULUS  SKIN HYDRATING TOPICAL FOAM CLO-1
clotrimazole aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0092-3	125 g in 1 CAN; Type 0: Not a Combination Product	08/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/01/2015

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0092) , analysis(13630-0092)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0092) , pack(13630-0092)