HOT SPICE AND ICE- menthol, capsicum oleoresin cream 
laiden montana emu products

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.

----------

Hot Spice and Ice Arthritis Pain Relieving Cream 2 oz

Active Ingredients

Active ingredients

Menthol 2.25%

Capsicum oleoresin 0.20%

Uses

Uses for the temporary relief of minor aches and pains of muscles and joints associated with:

Provides:

Warnings

For external use only

Do not use

Do not use

When using this product

When using this product

Stop use and ask a doctor if

Stop use and ask a doctor if

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

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

Purpose

Topical analgesic

Principal Display Panel

Hot Spice and Ice

Arthritis Pain Relieving Cream

Principal Display Panel

HOT SPICE AND ICE 
menthol, capsicum oleoresin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72895-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.28 g  in 56.7 g
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN113 mg  in 56.7 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72895-002-0256.7 g in 1 JAR; Type 0: Not a Combination Product06/01/2019
2NDC:72895-002-257.5 g in 1 JAR; Type 0: Not a Combination Product06/01/2019
3NDC:72895-002-04113.4 g in 1 JAR; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2019
Labeler - laiden montana emu products (960935344)
Establishment
NameAddressID/FEIBusiness Operations
laiden montana emu products960935344manufacture(72895-002)

Revised: 1/2020
Document Id: 98c11d0f-14c8-1044-e053-2a95a90a3532
Set id: 98c11d0f-14c7-1044-e053-2a95a90a3532
Version: 1
Effective Time: 20200101
 
laiden montana emu products