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NDC 71178-0775-02 FYZICAL SPORTS Pain Relief 1-COOL .35; 40 mg/mL; mg/mL Details

FYZICAL SPORTS Pain Relief 1-COOL .35; 40 mg/mL; mg/mL

FYZICAL SPORTS Pain Relief 1-COOL is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by S.P.O.R.T.S., LLC. The primary component is CAPSAICIN; MENTHOL.

Product Information

NDC	71178-0775
Product ID	71178-775_45c4536a-8635-749f-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	FYZICAL SPORTS Pain Relief 1-COOL
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL, CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.35; 40
Active Ingredient Units	mg/mL; mg/mL
Substance Name	CAPSAICIN; MENTHOL
Labeler Name	S.P.O.R.T.S., LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71178-0775-02 (71178077502)

Pricing Information	N/A
NDC Package Code	71178-775-02
Billing NDC	71178077502
Package	1 TUBE in 1 BOX (71178-775-02) / 60 mL in 1 TUBE
Marketing Start Date	2017-01-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 45c47849-9c9b-069b-e054-00144ff8d46c Details

DRUG FACTS

Active Ingredients

Menthol 4.00%

Capsaicin 0.035%

Purpose

Topical Analgesic

Indications:

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

Warnings:

For external use only.
Avoid contact with eyes.
If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.
Do not apply to wounds or damaged skin.
Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older:Apply to affected area not more than three to four times daily,
Children under two-years of age: consult a physician.

Other Ingredients:

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Ceteareth-20, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iles Paraguayensis (Yerba Mate) Extract, Methylsulfonylmethane (MSM), Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Squalane, Stearic Acid, Triethanolamine, Tocopheryl Acetate (Vitamin E), Trolamine Salicylate, FD&C Blue #1, FD&C Red #40.

Additional Information:

Store at room temperature.

Package Labeling:

INGREDIENTS AND APPEARANCE

FYZICAL SPORTS PAIN RELIEF 1-COOL

menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71178-775
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALMOND OIL (UNII: 66YXD4DKO9)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71178-775-02	1 in 1 BOX	01/03/2017
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/03/2017

Labeler - S.P.O.R.T.S., LLC (809986016)

Revised: 1/2017

Document Id: 45c4536a-8635-749f-e054-00144ff8d46c

Set id: 45c47849-9c9b-069b-e054-00144ff8d46c

Version: 1

Effective Time: 20170110