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

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.

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Essentials
Herbal Muscle Massage

Drug Facts

Active ingredientsPurpose
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

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Label
ESSENTIALS   HERBAL MUSCLE MASSAGE
capsicum oleoresin, racementhol, and methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-282
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.32 mg  in 1 g
RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42508-282-11113 g in 1 TUBE; Type 0: Not a Combination Product02/22/201208/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/22/201208/23/2023
Labeler - Arbonne International, LLC (961643454)
Registrant - Levlad, LLC (076245109)

Revised: 7/2023
 
Arbonne International, LLC