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WHITE FLOWER ANALGESIC BALM by JELMA PHILIPPINES INC

Medically reviewed on June 14, 2018

Dosage form: oil
Ingredients: CAMPHOR (SYNTHETIC) 6g in 100mL, MENTHOL 14.6g in 100mL, METHYL SALICYLATE 40g in 100mL
Labeler: JELMA PHILIPPINES INC
NDC Code: 51681-0001

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.

DRUG FACTS

Active ingredients
Camphor 6%
Menthol 15%
Methyl salicylate 40%

Purpose
External analgesic


Uses  For the temporary relief of minor aches and pains of muscles and joints due to
  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Do not use

  • on wounds
  • on irritated or damaged skin
  • on the face
  • otherwise than as directed

When using this product

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


Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
  • when using for pain of arthritis
    • pain persists for more than 10 days
    • redness is present
    • in conditions affecting children under 12 years of age

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 and children 3 years of age and older: Apply a few drops then gently rub into the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Do not use, consult your doctor.
  • Refer to the above warnings; use otherwise than as directed may be dangerous.

Other information

  • keep container tightly closed
  • store at 15º to 30ºC (59º to 86ºF)

Inactive ingredients
Eucalyptus oil, lavender oil and peppermint oil.

Questions or comments? (888)221-3496 M-F 9am to 5pm

  • you may also report serious side effects to this phone number

WHITE FLOWER ANALGESIC BALM  NDC-51681-0001-1  0.67 fl oz (20mL)

WHITE FLOWER ANALGESIC BALM 
camphor, menthol, and methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51681-0001
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)6 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL14.6 g  in 100 mL
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE40 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL 
LAVENDER OIL 
PEPPERMINT OIL 
Packaging
#Item CodePackage Description
1NDC:51681-0001-120 mL in 1 BOTTLE, GLASS
2NDC:51681-0001-210 mL in 1 BOTTLE, GLASS
3NDC:51681-0001-42.5 mL in 1 BOTTLE, GLASS
4NDC:51681-0001-35 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/14/2010
Labeler - JELMA PHILIPPINES INC (721085447)

 
JELMA PHILIPPINES INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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