PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON- menthol gel 
RB Health (US) 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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PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON

Drug Facts

Active Ingredients

Menthol 3.5%

Purpose

Pain Relieving Gel

Uses:

Temporarily relieves minor aches and pains of muscles and joints associated with:

Warnings

​For external use only.

Flammable:

Keep away from excessive heat and open flame.

When Using This Product:

  • use only as directed
  • Avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop Use and Ask Doctor If:

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding, ask a health professional before use.

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

Directions:

Other Information:

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 Sylvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water.

Questions or Comments?

1-800-246-3733

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

NDC 59316-112-10

PERFORM®

MENTHOL-PAIN
RELIEVING
GEL
COOL + SOOTHING
FOR SORE MUSCLES
AND JOINTS

FAST-ACTING

ROLL-ON

3 FL OZ (89 mL)

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)  
ORANGE OIL, COLD PRESSED (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-112-101 in 1 CARTON05/18/2015
189 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/18/2015
Labeler - RB Health (US) LLC (081049410)

Revised: 2/2022
Document Id: 8be06192-9594-45be-b69f-8499984b559b
Set id: 8af185ad-719e-4684-89c0-9c17c1277499
Version: 6
Effective Time: 20220203
 
RB Health (US) LLC