Label: HC MAX ANTI FUNGAL- tolnaftate 1% ointment
- NDC Code(s): 0295-6629-06
- Packager: Denison Pharmaceuticals, LLC
- 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 December 11, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- Clean affected area with soap and warm water and dry throrughy
- Apply a thin layer of HC Max TM Anti-fungal Ointment over affeted area twice daily (morning and night) or as directed by a doctor.
- Wear well-fitting, ventilated shoes, and change shoes and socks at least once dialy.
- For athlete's foot pay special atnetion to spaces between the toes.
- For athlete's foot and ringworm, use daily for 4 weeks.
- For toes fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Supervise children in the use of this product.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HC MAX ANTI FUNGAL
tolnaftate 1% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-6629 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE 350 (UNII: 2Y53S6ATLU) EUCALYPTOL (UNII: RV6J6604TK) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) LAVENDER OIL (UNII: ZBP1YXW0H8) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLOXAMER 188 (UNII: LQA7B6G8JG) ALOE VERA LEAF (UNII: ZY81Z83H0X) TEA TREE OIL (UNII: VIF565UC2G) OLIVE OIL (UNII: 6UYK2W1W1E) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-6629-06 28 g in 1 TUBE; Type 0: Not a Combination Product 07/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/11/2019 Labeler - Denison Pharmaceuticals, LLC (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 manufacture(0295-6629)