MUSCLE RUB- menthol gel 
OL PHARMA TECH,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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ACTIVE INGREDIENT

MENTHOL 2.5%

PURPOSE

TOPICAL ANALGESIC

USES

temporarily relieves the minor aches and pains of muscles and joints associated with:

WARNINGS

For external use only

Do not use

Do not use


Ask a doctor before use if you have redness over the affected area.

When using this product

Stop use and ask your doctor

Stop use and ask your doctor if:

Keep out of reach of children



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

Directions

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients


vitamin E, propylene glycol, polysorbate 80, water, isopropyl alcohol, carbomer interpolymer type A, EDTA , methylparaben, propylparaben

Questions

www.drspharmacyusa.com

MUSCLE RUB 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
Colorwhite (TRANSLUCENT) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80489-004-011 in 1 CARTON01/01/2021
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:80489-004-021 in 1 CARTON01/01/2021
249.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2021
Labeler - OL PHARMA TECH,LLC (021170377)
Registrant - OL PHARMA TECH,LLC (021170377)
Establishment
NameAddressID/FEIBusiness Operations
OL PHARMA TECH,LLC (Drs. pharmacy)021170377manufacture(80489-004)

Revised: 10/2023
Document Id: 06b953b5-4f96-774b-e063-6294a90a79b0
Set id: b22c7999-52d5-25c3-e053-2a95a90a01f5
Version: 4
Effective Time: 20231002
 
OL PHARMA TECH,LLC