WHITE FLOWER ANALGESIC BALM: Package Insert and Label Information

WHITE FLOWER ANALGESIC BALM- 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 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

Warnings
For external use only

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51681-0001 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 6 g in 100 mL MENTHOL (MENTHOL) MENTHOL 14.6 g in 100 mL METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 40 g in 100 mL

Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL LAVENDER OIL PEPPERMINT OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51681-0001-1 20 mL in 1 BOTTLE, GLASS None 2 NDC:51681-0001-2 10 mL in 1 BOTTLE, GLASS None 3 NDC:51681-0001-4 2.5 mL in 1 BOTTLE, GLASS None 4 NDC:51681-0001-3 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 06/14/2010

Labeler — JELMA PHILIPPINES INC (721085447)

Revised: 10/2018 JELMA PHILIPPINES INC