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WHITE FLOWER ANALGESIC BALM FLORAL SCENTED

Medically reviewed on July 30, 2018

Dosage form: oil
Ingredients: CAMPHOR (SYNTHETIC) 5.4g in 100mL, MENTHOL 13.0g in 100mL, METHYL SALICYLATE 35.8g in 100mL
Labeler: JELMA PHILIPPINES INC
NDC Code: 51681-0011

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 5.4%
Menthol 13.1%
Methyl salicylate 36%

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 irritated or damaged skin
  • on wounds
  • 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 ag

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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
  • children under 3 years of age and pregnant women: do not use, consult a physician
  • refer to the above warnings; use otherwise than as directed may be dangerous

Other information

  • keep tightly sealed
  • store at or below 30º C (86º F), away from direct sunlight

Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.

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

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

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-51681-0011-1  0.338 FL OZ (10 ML)

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED 
camphor, menthol and methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51681-0011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)5.4 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL13.0 g  in 100 mL
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE35.8 g  in 100 mL
Packaging
#Item CodePackage Description
1NDC:51681-0011-110 mL in 1 BOTTLE, GLASS
2NDC:51681-0011-25 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/2010
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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