Label: HOT SPICE AND ICE- menthol, capsicum oleoresin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72895-002-02, 72895-002-04, 72895-002-25 - Packager: laiden montana emu products
- 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 January 1, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
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Inactive Ingredients
Inactive ingredients Aloe Barbadensis (Aloe) Leaf Gel, Emu Oil, Vitis Vinifera (Grape) Seed Oil, Beeswax, Mixed Tocopherol, Arnica Montana Flower, Mentha Piperita (Peppermint) Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Melaleuca Leucadendron Cajaputi (Cajeput) Oil, Capsicum Frutescens (Capsicum) Oil, Xanthan Gum
- Purpose
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
HOT SPICE AND ICE
menthol, capsicum oleoresin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72895-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.28 g in 56.7 g CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN 113 mg in 56.7 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) XANTHAN GUM (UNII: TTV12P4NEE) METHYL SALICYLATE (UNII: LAV5U5022Y) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) GRAPE SEED OIL (UNII: 930MLC8XGG) YELLOW WAX (UNII: 2ZA36H0S2V) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) PEPPERMINT OIL (UNII: AV092KU4JH) TABASCO PEPPER (UNII: J1M3NA843L) EMU OIL (UNII: 344821WD61) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72895-002-02 56.7 g in 1 JAR; Type 0: Not a Combination Product 06/01/2019 2 NDC:72895-002-25 7.5 g in 1 JAR; Type 0: Not a Combination Product 06/01/2019 3 NDC:72895-002-04 113.4 g in 1 JAR; Type 0: Not a Combination Product 06/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2019 Labeler - laiden montana emu products (960935344) Establishment Name Address ID/FEI Business Operations laiden montana emu products 960935344 manufacture(72895-002)
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