![OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]](https://medic.hrt.org//dailymed/images/a91d077f-8f9e-48fd-8554-0428bdfe1eb7/13630-0090-3.jpg)
| NDC | 13630-0090-3 |
| Set ID | a91d077f-8f9e-48fd-8554-0428bdfe1eb7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Packaging, Inc. |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | PART333C |
- PRINCIPAL DISPLAY PANEL - 125g Can Label
- Active Ingredient
- Purpose
- Uses
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Warnings: For external use only
When using this product: • Avoid contact with the eyes.
• Do not use on deep or puncture wounds, infections or lacerations.
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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, Propylene, glycol, Butane, Palmitic acid, Stearic acid, Propane, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl acetate, Disodium EDTA, Ubiquinone
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INGREDIENTS AND APPEARANCE
OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM
clotrimazole aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0090 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) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) UBIDECARENONE (UNII: EJ27X76M46) WATER (UNII: 059QF0KO0R) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0090-3 125 g in 1 CAN; Type 0: Not a Combination Product 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 Packaging, Inc. 805987059 label(13630-0090) , pack(13630-0090) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0090)
