Label: PAIN BE GONE- menthol cream
- NDC Code(s): 82721-001-01, 82721-001-02
- Packager: Back to Earth Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 13, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- PURPOSE
-
WARNINGS
■ For external use only.
■ Avoid Contact with the eyes. If conditions worsen, or if symptoms
persist for more that 7 days or clear up and occur again within a few
days, discontinue use of this product and consult a physician/doctor.
■ Do not apply to wounds or damaged skin.■ Do not bandage tightly.
■ Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away. - DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin,
Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil
Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil,
Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens
(Wintergreen) Oil, Cinnamomum Camphora (White) Oil,
Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80. - KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN BE GONE
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82721-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 9.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) EUCALYPTUS OIL (UNII: 2R04ONI662) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) METHYL SALICYLATE (UNII: LAV5U5022Y) ARNICA MONTANA (UNII: O80TY208ZW) CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) MENTHA PIPERITA (UNII: 79M2M2UDA9) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82721-001-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 07/27/2023 2 NDC:82721-001-02 120 mL in 1 TUBE; Type 0: Not a Combination Product 07/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 07/27/2023 Labeler - Back to Earth Inc. (203365416) Registrant - Back to Earth Inc. (203365416)