HC Max Anti-Fungal Ointment

HC Max Anti Fungal by

Drug Labeling and Warnings

HC Max Anti Fungal by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HC MAX ANTI FUNGAL- tolnaftate 1% ointment 
Denison Pharmaceuticals, LLC

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.

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HC Max Anti-Fungal Ointment

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

Uses

• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
• Helps prevent most athlete's foot with daily use.
• For effective relief of itching, burning and cracking.

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

• avoid contact with eyes.

Stop use and ask a doctor if

• Irratation occurs.
• There is no improvement within 4 weeks.

KEEP THIS AND ALL MEICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physican, emercy medical car facility or Poison Control Center immediately for advice.

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 information

Store at controlled room temperature 15º-30º C (59º-86ºF) Do not permit to freeze.

Inactive Ingredients

Purified Water USP, Carborner Homopolymer Type A (Alyl Pentaerythritol Crosslinked), Phenoxyethanol. Dimethicone 350, Glyceryl Monostearate, Poloxamer 188, Aloe Vera Leaf, Eucalyptol, Lavender Oil, Olive Oil, Tea Tree Oil, Sodium Hydroxide.

HC MAX ANTI FUNGAL 
tolnaftate 1% ointment

Product 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)

Revised: 12/2020

Document Id: b633f741-f164-88ad-e053-2a95a90ad75a

34390-5

Set id: b6340e63-c5be-88af-e053-2995a90a7b7c

Version: 1

Effective Time: 20201211