Label: AKIN ANTI-FUNGAL- clotrimazole solution
- NDC Code(s): 69822-254-05
- Packager: Southern Sales & Service, 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.
Updated January 1, 2017
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- Active Ingredient
- Inactive Ingredients:
Read all package directions and warnings before using.
- Wash affected area and dry thoroughly.
- Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
- For athlete’s foot: pay special attention to spaces between 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.
- Supervise children in the use of this product.
- Questions? Comments?
- PRINCIPAL DISPLAY PANEL
- Akin Antifungal Solution .5oz/15ml
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-254 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 mL Inactive Ingredients Ingredient Name Strength GLYCINE (UNII: TE7660XO1C) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) MENTHA PIPERITA (UNII: 79M2M2UDA9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69822-254-05 1 in 1 CARTON 01/01/2017 1 15 mL in 1 BOTTLE; 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 01/01/2017 Labeler - Southern Sales & Service, Inc. (013114906) Establishment Name Address ID/FEI Business Operations Southern Sales & Service, Inc. 013114906 LABEL(69822-254) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(69822-254)