Label: PAIN-X- menthol gel
- NDC Code(s): 80489-003-01, 80489-003-02
- Packager: OL PHARMA TECH,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 17, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use
- Ask a doctor before use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN-X
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80489-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 25 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white (TRANSLUCENT) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80489-003-01 1 in 1 CARTON 01/01/2021 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:80489-003-02 1 in 1 CARTON 01/01/2021 2 49.6 g in 1 TUBE; 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 01/01/2021 Labeler - OL PHARMA TECH,LLC (021170377) Registrant - OL PHARMA TECH,LLC (021170377) Establishment Name Address ID/FEI Business Operations OL PHARMA TECH,LLC (Drs. Pharmacy) 021170377 manufacture(80489-003)