Label: SOOTHE- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81771-7001-1 - Packager: Clay Therapy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 14, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- PURPOSE
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOOTHE
menthol creamProduct 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)
