ATHLETESGEL- capsaicin, menthol, methyl salicylate gel

AthletesGel by

Drug Labeling and Warnings

AthletesGel by is a Otc medication manufactured, distributed, or labeled by Hammock Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Capsaicin 0.025%

Menthol 8%

Methyl salicylate 27%

PURPOSE

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

INDICATIONS & USAGE

Uses Temporarily relieves the minor aches, pains and inflammation of muscles and joints associated with:

• strains
• sprains
• bruises
• arthritis

WARNINGS

Warnings

For external use only

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

When using this product

• avoid contact with eyes and mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms last more than 7 days or clear up
• condition clears up and occurs again within a few days
• excessive rash or irritation develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• use only as directed
• adults and children 12 years and over:
• apply to affected area not more than 3 times daily
• start with a small amount to assess heat before applying more
• wash hands with soap and water after use
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information
store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

allantoin, almond oil, arnica, clove bud oil, colloidal anhydrous silica, diethylene glycol monoethyl ether

QUESTIONS

Questions? 877-323-6999

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Distributed by:

Hammock Pharmaceuticals.

Charlotte, NC 28723 USA

www.athletesgel.us

Licensed by Athletes Gel. Manufactured in Australia.

PRINCIPAL DISPLAY PANEL

Pain Relief Mild Musculoskeletal Injuries

ATHLETES GEL™

Capsain 0.025% Menthol 8% Methyl Salicylate 27%

Topical Analgesic

NATURAL ALMOND OIL BASE with Arnica

NET WT 1.8 oz (50g)

INGREDIENTS AND APPEARANCE

ATHLETESGEL 
capsaicin, menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71341-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	27 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
ARNICA MONTANA (UNII: O80TY208ZW)
ALLANTOIN (UNII: 344S277G0Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71341-001-50	1 in 1 CARTON	10/01/2019
1		50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71341-001-20	1 in 1 CARTON	10/01/2019
2		20 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71341-001-80	1 in 1 CARTON	10/01/2019
3		80 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2019

Labeler - Hammock Pharmaceuticals, Inc. (080576886)