Soothe by Clay Therapy SOOTHE- menthol cream

Soothe by

Drug Labeling and Warnings

Soothe by is a Otc medication manufactured, distributed, or labeled by Clay Therapy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

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

DOSAGE & ADMINISTRATION

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.

ACTIVE INGREDIENT

Menthol 2.5%

PURPOSE

Topical Analgesic

WARNINGS

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.

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81771-7001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81771-7001-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	05/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/19/2021

Labeler - Clay Therapy (204269414)

Registrant - Clay Therapy (204269414)