HOT SPICE AND ICE- menthol, capsicum oleoresin cream

Hot Spice and Ice by

Drug Labeling and Warnings

Hot Spice and Ice by is a Otc medication manufactured, distributed, or labeled by laiden montana emu products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• simple backache
• arthritis
• strains
• bruises
• sprains

Provides:

• penetrating pain relief

Warnings

For external use only

Do not use

Do not use

• on wounds or damaged skin
• with heat

When using this product

When using this product

• avoid contact with eyes and mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

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

• Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• massage into area until thoroughly absorbed
• Children under 12 years of age: consult a doctor.

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

DOSAGE & ADMINISTRATION

Principal Display Panel

Hot Spice and Ice

Arthritis Pain Relieving Cream

Display Panel

INGREDIENTS AND APPEARANCE

HOT SPICE AND ICE 
menthol, capsicum oleoresin cream

Product 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)