PAIN RELIEVING FOOT- menthyl salicylate and menthol, unspecified form cream

Pain Relieving Foot by

Drug Labeling and Warnings

Pain Relieving Foot by is a Otc medication manufactured, distributed, or labeled by Brandable, Garcoa Laboratories, Sigan Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Menthol 10.0%	Topical Analgesic
Methyl Salicylate 15.0%	Topical Analgesic

Uses

• For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises and sprains.

Warnings

For external use only.

• Avoid contact with the eyes and mucous membranes.

• Do not use with any other topical ointment, sprays, creams or liniments.
• Do not use with heating pads or heating devices.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

• If pregnant or nursing: Consult a physician.

• Do not apply to wounds or damaged skin.
• Do not bandage tightly.

Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 6 years of age: Consult a doctor.
• Retain carton for full product information.

Other information

Store at room temperature.

Inactive ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone, Dimethyl Sulfone, Emu Oil, Fragrance, Glucosamine HCl, Panthenol, Phenoxyethanol, Polysorbate 20, Red 33, Sodium Chondroitin Sulfate, Sodium Hydroxide, Stearic Acid, Water, Zingiber Officinale (Ginger) Root Extract.

Questions?

Call toll-free (877) 281-3001

SPL UNCLASSIFIED SECTION

Distributed by Brandable® Inc.
269 S. Beverly Dr., Suite 8,
Beverly Hills, CA 90212

PRINCIPAL DISPLAY PANEL - 85 G Container Box

FOOT
RELIEF

Good Foundation

Pain Relieving Cream

aloe vera + menthol
cool heating rub for
extra strength pain relief

NET WT 3 OZ (85 G)

INGREDIENTS AND APPEARANCE

PAIN RELIEVING FOOT 
menthyl salicylate and menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72764-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (Salicylic Acid - UNII:O414PZ4LPZ)	MENTHYL SALICYLATE, (+/-)-	750 mg  in 5 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	500 mg  in 5 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Stearic Acid (UNII: 4ELV7Z65AP)
Cetyl Alcohol (UNII: 936JST6JCN)
Emu Oil (UNII: 344821WD61)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
Dimethicone (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Allantoin (UNII: 344S277G0Z)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GINGER (UNII: C5529G5JPQ)
Panthenol (UNII: WV9CM0O67Z)
Polysorbate 20 (UNII: 7T1F30V5YH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
Phenoxyethanol (UNII: HIE492ZZ3T)
Benzyl Alcohol (UNII: LKG8494WBH)
Sodium Hydroxide (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72764-004-01	1 in 1 BOX	04/01/2020
1		85 g in 1 CONTAINER; 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	04/01/2020

Labeler - Brandable (080414109)

Registrant - Garcoa Laboratories (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries		255106239	MANUFACTURE(72764-004)