PAIN-X- 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

Ask a doctor before use

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

When using this product

Stop use and ask a doctor if

Stop use and ask a 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

Inactive ingredients

Vitamin E, Propylene glycol,Polysorbate 80,Water, Isopropyl alcohol,Carbomer interpolymer typ A, edta, Methylparaben, Propylparaben.

Questions

www.drspharmacyusa.com

Pain X

PAIN-X 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-003
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
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (TRANSLUCENT) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80489-003-011 in 1 CARTON01/01/2021
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:80489-003-021 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(80489-003)

Revised: 1/2023
Document Id: f2733fd6-4928-0f00-e053-2a95a90a0006
Set id: b22bb19a-14e5-3d32-e053-2a95a90ae520
Version: 3
Effective Time: 20230117
 
OL PHARMA TECH,LLC