NUMM WARM SIZZLE- menthol camphor gel

NUMM WARM SIZZLE by

Drug Labeling and Warnings

NUMM WARM SIZZLE by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS INC., SOMBRA COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Camphor 3%, Menthol 3%

Purpose

Purpose External Analgesic

Keep out of reach of childern

Keep out of reach of childern

Uses

Temporarily relieves minor aches and pains of muscles and joints with: simple backaches,strains, bruises, and sprains

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice,camellia sinensis (green tea) leaf extract, caprylyl glycol, capsicum annuum fruit extract, carbomer, citrus aurntium dulcis (orange) peel oil, citrus grandis (grapefruit) seed extract, decyl glucoside, filipendula ulmaria flower (queen of the prairie) extract, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbornate, yucca schidigera stem extract,

Question or comments

1-800-225-3963

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUMM WARM SIZZLE 
menthol camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-4400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	.03 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
CAPSICUM (UNII: 00UK7646FG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
WITCH HAZEL (UNII: 101I4J0U34)
ORANGE OIL (UNII: AKN3KSD11B)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CARBONATE (UNII: 45P3261C7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-4400-1	226.8 g in 1 JAR; Type 0: Not a Combination Product	10/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	10/11/2023

Labeler - SOMBRA COSMETICS INC. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS		097464309	manufacture(61577-4400) , label(61577-4400)