Your browser does not support JavaScript! CARE ONE PAIN RELIEF (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [AMERICAN SALES COMPANY]
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CARE ONE PAIN RELIEF (camphor, menthol, methyl salicylate) cream
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredients in Ultra Strength Bengay®

Fast Relief from Minor Arthritis, Backache, Muscle & Joint Pain

ULTRA STRENGTH

PAIN RELIEF CREAM

GREASELESS

PAIN RELIEVING CREAM

Pain Relief Cream Carton Image 1

Pain Relief Cream Carton Image 1

Pain Relief Cream Carton Image 2

Pain Relief Cream Carton Image 2

CARE ONE PAIN RELIEF 
camphor, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-049
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-049-161 in 1 CARTON
157 g in 1 TUBE
2NDC:41520-049-261 in 1 CARTON
2113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2008
Labeler - American Sales Company (809183973)

Revised: 11/2011
 
American Sales Company

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