Label: OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1- clotrimazole aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0092-3 - Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 17, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
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
- PRINCIPAL DISPLAY PANEL - 125 g Can Label
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INGREDIENTS AND APPEARANCE
OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1
clotrimazole aerosol, foamProduct 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)