Label: TOUCHLESS CARE ANTIFUNGAL spray
- NDC Code(s): 69502-001-57
- Packager: Crawford Healthcare, 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 February 16, 2017
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- Official Label (Printer Friendly)
- Active Ingredient
- Stop use and ask a doctor if
- Keep out of reach of children.
- Cleanse the affected area and allow to dry.
- Shake bottle well before use.
- Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required.
- For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor. This product is not effective on the scalp or nails.
- Other Information
- Inactive Ingredients
- SPL Unclassified Section
- Package Label
INGREDIENTS AND APPEARANCE
TOUCHLESS CARE ANTIFUNGAL
touchless care antifungal spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69502-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) MINERAL OIL (UNII: T5L8T28FGP) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) PETROLATUM (UNII: 4T6H12BN9U) ZINC OXIDE (UNII: SOI2LOH54Z) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) CHOLECALCIFEROL (UNII: 1C6V77QF41) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69502-001-57 57 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/28/2017 Labeler - Crawford Healthcare, Inc. (042813710)