DZA Brands, LLC Muscle Rub Drug Facts

Healthy Accents Muscle Rub by

Drug Labeling and Warnings

Healthy Accents Muscle Rub by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS MUSCLE RUB- menthol, methyl salicylate cream 
DZA Brands 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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DZA Brands, LLC Muscle Rub Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 15%

Purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use

  • other than as directed
  • on children under 12 years of age
  • with a heating pad (may blister skin)

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • skin redness or excessive irritation of the skin develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children

to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician

Other information

  • store at 20°-25°C (68°-77°F)
  • Lot No. & Exp. Date, see crimp of tube and see box

Inactive ingredients

citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Bengay® active ingredients

regular strength

muscle rub

non-greasy – pain relieving cream

fast relief from minor arthritis, backache, muscle & joint pain

NET WT 3 OZ (85g)

Healthy Accents Muscle Rub.jpg
HEALTHY ACCENTS MUSCLE RUB 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55316-563
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55316-563-211 in 1 CARTON11/20/201306/06/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/20/201306/06/2019
Labeler - DZA Brands LLC (090322194)

Revised: 11/2019
Document Id: 3433b1e4-9c08-47b7-946a-802d46e2cea7
Set id: 7ed3707f-0ccb-40d5-8d7c-f3f214d06d3a
Version: 2
Effective Time: 20191118
 
DZA Brands LLC