PRECISE  PAIN RELIEVING - menthol and methyl salicylate cream 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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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PRECISE™
EXTRA STRENGTH
PAIN RELIEVING

Drug Facts

Active ingredientsPurpose
Menthol 10% Topical analgesic
Methyl salicylate 30%Topical analgesic

Uses

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

  • simple backache
  • arthritis
  • sprains
  • bruises
  • strains

Warnings

For External Use Only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

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
  • excessive skin irritation occurs

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • use only as directed
  • adults and 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 between 20–25°C (68–77°F). Protect from freezing.

Inactive ingredients

C12-15 alkyl benzoate, carbomer, cocoglycerides, distearyl ether, edetate disodium, ethylparaben, fragrance, glyceryl laurate, hydrogenated vegetable glycerides, methylparaben, myristyl alcohol, phenoxyethanol, propylparaben, sodium hydroxide, steareth-2, steareth-21, stearyl alcohol, water

Questions or comments?

call 1-800-962-5357 (toll free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-597-02

FAST TARGETED RELIEF
START TO FEEL ON CONTACT

FROM THE MAKERS OF
TYLENOL®

PRECISE™

EXTRA STRENGTH
PAIN RELIEVING
CREAM

TARGETED RELIEF FOR
MUSCLE AND JOINT PAIN

2.5 oz CREAM

PRINCIPAL DISPLAY PANEL
PRECISE   PAIN RELIEVING
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-597
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol0.1 g  in 1 g
Methyl salicylate (Methyl salicylate) Methyl salicylate0.3 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
alkyl (C12-15) benzoate 
edetate disodium 
ethylparaben 
glyceryl laurate 
glyceryl monostearate 
methylparaben 
myristyl alcohol 
phenoxyethanol 
propylparaben 
sodium hydroxide 
steareth-2 
stearyl alcohol 
water 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-597-021 in 1 CARTON
170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/201006/30/2014
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 7/2014
Document Id: 4a710619-5aeb-4c65-88c9-0473fcd29e1b
Set id: 742512d1-6fb4-48ec-be89-a58b50c645fa
Version: 3
Effective Time: 20140722
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc