PAIN BE GONE- menthol cream 
Back to Earth Inc.

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back to earth

Active Ingredients

Menthol 9.6%

Pain Relieving Gel

■ 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.

■ Adults and children 2 years of age and older:
Apply to affected area not more than 3 to 4 times daily.
■ Children under 2 years of age: consult a Physician/Doctor

■ For the temporary relief of minor aches and pains of muscles and joints
associated with simple backache, arthritis, strains, bruises, and sprains.
For penetrating pain relief.

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. In case of overdose, get medical help
or contact a Poison Control Center right away.

Principal Display Panel

PAIN BE GONE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82721-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82721-001-0150 mL in 1 TUBE; Type 0: Not a Combination Product07/27/2023
2NDC:82721-001-02120 mL in 1 TUBE; Type 0: Not a Combination Product07/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01407/27/2023
Labeler - Back to Earth Inc. (203365416)
Registrant - Back to Earth Inc. (203365416)

Revised: 2/2023
Document Id: f49e718b-ef8a-b648-e053-2a95a90a96c8
Set id: f49e718b-ef89-b648-e053-2a95a90a96c8
Version: 1
Effective Time: 20230213
 
Back to Earth Inc.