PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON- menthol gel

PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON by

Drug Labeling and Warnings

PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON by is a Otc medication manufactured, distributed, or labeled by Performance Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses:

Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort and arthritis.

Warnings:

​For external use only.

Flammable:

Keep away from excessive heat and open flame.

Ask a Doctor Before Using If You:

Have sensitive skin, are pregnant or are breastfeeding.

When Using This Product:

• Avoid contact with eyes or mucous membranes
• Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops
• Do not bandage or use with a heating pad or device, ointments, creams, sprays, liniments
• Wash hands with cool water after using

Stop Use and Ask Doctor If:

Condition worsens, symptoms persist more than 7 days, or clear up and reoccur.

Keep Out of Reach of Children:

If ingested, get medical help.  Contact Poison Control Center immediately.

Directions:

• Adults/Children 2 years or older:  Massage onto affected area up to 4 times daily.
• Children under 2 years of age: Consult a physician.

Other Information:

Store in a cool, dry place with lid close tightly.

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camelia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (lime) Oil, Citrus Auratium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kerneol Oil, Pinus Sytvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water.

Questions or Comments?

info@performpainrelief.com   1-800-755-2584

Product Label

INGREDIENTS AND APPEARANCE

PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LIME OIL (UNII: UZH29XGA8G)
ORANGE OIL (UNII: AKN3KSD11B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
HYPERICUM OIL (UNII: OZU2FC70HY)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAVANDIN OIL (UNII: 9RES347CKG)
PEPPERMINT OIL (UNII: AV092KU4JH)
NUTMEG OIL (UNII: Z1CLM48948)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THYME OIL (UNII: 2UK410MY6B)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-112-10	1 in 1 CARTON	05/18/2015
1		89 mL in 1 BOTTLE; 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	05/18/2015

Labeler - Performance Health, LLC (794324061)