WHITE FLOWER ANALGESIC BALM FLORAL SCENTED: Package Insert and Label Information

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED — camphor (synthetic), menthol and methyl salicylate oil
JELMA PHILIPPINES 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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51681-0011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 5.4 g in 100 mL MENTHOL (MENTHOL) MENTHOL 13.0 g in 100 mL METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 35.8 g in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51681-0011-1 10 mL in 1 BOTTLE, GLASS None 2 NDC:51681-0011-2 5 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/20/2010

Labeler — JELMA PHILIPPINES INC (721085447)

Revised: 07/2010 JELMA PHILIPPINES INC