- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Indications
- Warnings
- Directions
- Other Information
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Inactive Ingredients
Benzyl Alcohol, Butylparaben, Carbomer, Esterified Fatty Acids (Proprietary Blend), Ethylparaben, Glycerin, Glyceryl Stearate, Isobutylparaben, Lecithin, Methylparaben, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Peppermint Oil, Phenoxyethanol, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Water.
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113G Jar Label
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INGREDIENTS AND APPEARANCE
EFAC PAIN RELIEVING
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55722-419 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 12.5 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHYLPARABEN (UNII: A2I8C7HI9T) OLIVE OIL (UNII: 6UYK2W1W1E) PEG-100 STEARATE (UNII: YD01N1999R) PEPPERMINT OIL (UNII: AV092KU4JH) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPYLPARABEN (UNII: Z8IX2SC1OH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55722-419-02 113 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2012 Labeler - Imagenetix (091209341) Registrant - Lifetech Resources, LLC (662559110) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC 622559110 MANUFACTURE(55722-419)