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Healthy Accents muscle ultra strength

Dosage form: cream
Ingredients: CAMPHOR (SYNTHETIC) 4g in 100g, MENTHOL 10g in 100g, METHYL SALICYLATE 30g in 100g
Labeler: DZA Brands LLC
NDC Code: 55316-049

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.

DZA Brands, LLC Muscle Rub Drug Facts

Active ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

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

When using this product
  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad

Stop use and ask a doctor if
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive skin irritation develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • use only as directed
  • 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: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer type C, edetate disodium, glyceryl monostearate, lanolin anhydrous, PEG-100 stearate, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Questions or comments? 1-866-322-2439

Principal Display Panel

Compare to Ultra Strength Bengay® active ingredients

ultra strength

muscle rub

non-greasy

pain relieving cream

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

Muscle Rub Carton Image 1

Muscle Rub Carton Image 2

HEALTHY ACCENTS MUSCLE  ULTRA STRENGTH
camphor, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-049
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
POLYSORBATE 80 
POTASSIUM HYDROXIDE 
WATER 
STEARIC ACID 
TROLAMINE 
CARBOMER HOMOPOLYMER TYPE C 
PEG-100 STEARATE 
LANOLIN 
Packaging
#Item CodePackage Description
1NDC:55316-049-261 TUBE (TUBE) in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/25/2010
Labeler - DZA Brands LLC (090322194)

Revised: 08/2010
Document Id: d2ecd233-b86d-45f0-b8bd-2818eb167a13
Set id: d2ecd233-b86d-45f0-b8bd-2818eb167a13
Version: 1
Effective Time: 20100825
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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