ESSENTIALS HERBAL MUSCLE MASSAGE- capsicum oleoresin, racementhol, and methyl salicylate gel

Essentials by

Drug Labeling and Warnings

Essentials by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC, Levlad, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Capsaicin 0.032%	Topical Analgesic
Menthol 5%	Topical Analgesic
Methyl salicylate 10%	Topical Analgesic

Uses

• for temporary relief of minor aches and pains of muscles and joints associated with simple back ache, arthritis, strains, bruises and sprains

Warnings

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylate, consult a doctor before using

When using this product

• do not get into eyes. If contact occurs, rinse eyes thoroughly with water
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if

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

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

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, and consult a doctor

Other information

Store at 25°C–30°C (77°F–86°F)

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, anthemis nobilis flower extract, arnica montana flower extract, butylene glycol, calendula officinalis flower extract, disodium EDTA, eucalyptus globulus leaf oil, hamamelis virginiana (witch hazel) extract, lecithin, phenoxyethanol, water.

Questions or comments?

1.800.272.6663 Monday-Friday
6 a.m.–6 p.m. Pacific time

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Distributed by
Arbonne International, LLC
9400 Jeronimo Road, Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

ARBONNE
essentials™

HERBAL
MUSCLE MASSAGE
PAIN RELIEVING GEL

• Non-greasy
• Fast-absorbing
• Penetrating pain relief

Net wt. 4 oz./113 g

INGREDIENTS AND APPEARANCE

ESSENTIALS   HERBAL MUSCLE MASSAGE
capsicum oleoresin, racementhol, and methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY)	CAPSAICIN	0.32 mg  in 1 g
RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860)	RACEMENTHOL	50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-282-11	113 g in 1 TUBE; Type 0: Not a Combination Product	02/22/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/22/2012

Labeler - Arbonne International, LLC (021541164)

Registrant - Levlad, LLC (076245109)