SOOTHE- menthol cream 
Clay Therapy

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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Purified water, Glycerin, Mentha Arvensis Leaf Essential Oil, Helianthus Annuus (Sunflower) Seed Oil, Arnica Montana Flower Extract, Canadian Colloidal Clay, Sodium Carbomer, Caprylyl Glycol, Phenoxyethanol, Citrus Limon (Lemon) Peel Essential Oil, Rosmarinus Officinalis (Rosemary) Leaf Essential Oil, Eucalyptus Globulus Leaf Essential Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Pine (Pinus sylvestris) Essential Oil, Cinnamomum Camphora (Camphor) Bark Essential Oil, Polysorbate 80

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.

Menthol 2.5%

Topical Analgesic

For external use only. Use only as directed.

Stop use and ask doctor if - Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product - Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly

Flammable - Keep away from fire or flame.

If pregnant or breastfeeding, ask a health care professional before use.

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

For the temporary relief of minor aches and pains of muscles and joints.

Soothe

SOOTHE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81771-7001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PINUS SYLVESTRIS WHOLE (UNII: VP00HZL9IC)  
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CINNAMOMUM CAMPHORA LEAFY TWIG (UNII: 6RGO3JFT61)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
BENTONITE (UNII: A3N5ZCN45C)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81771-7001-160 mL in 1 TUBE; Type 0: Not a Combination Product05/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/2021
Labeler - Clay Therapy (204269414)
Registrant - Clay Therapy (204269414)

Revised: 2/2022
Document Id: d8005abc-2f81-2d28-e053-2a95a90a45fe
Set id: c2b427c0-9612-7153-e053-2995a90aa6d0
Version: 6
Effective Time: 20220214
 
Clay Therapy