WHITE FLOWER ANALGESIC BALM: Package Insert and Label Information

WHITE FLOWER ANALGESIC BALM- camphor (synthetic), menthol and methyl salicylate oil
MACAU-UNION PHARMACEUTICAL LTD

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
External analgesic
External analgesic

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
  • 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 4 times daily.
• For younger children, consult your doctor.

Other information

• keep container tightly closed
• store at 15° to 30°C (59° to 86°F)

Inactive ingredients Eucalyptus oil, lavender oil and peppermint oil.

Questions or comments? +1-626-823-9933 M-F 9am to 5pm

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

Uses For the temporary relief of minor aches and pains of muscles and joints due to

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings
For external use only

WHITE FLOWER ANALGESIC BALM

NDC 48256-0002-1

0.676 fl oz (20 ml)

WHITE FLOWER ANALGESIC BALM camphor, menthol, methyl salicylate oil

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63047-0002 Route of Administration TOPICAL 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 14.5 g in 100 mL METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 40.02 g in 100 mL

Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL LAVENDER OIL PEPPERMINT OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63047-0002-1 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS 1 20 mL in 1 BOTTLE, GLASS This package is contained within the BOX (63047-0002-1) 2 NDC:63047-0002-2 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS 2 10 mL in 1 BOTTLE, GLASS This package is contained within the BOX (63047-0002-2) 3 NDC:63047-0002-3 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS 3 5 mL in 1 BOTTLE, GLASS This package is contained within the BOX (63047-0002-3) 4 NDC:63047-0002-4 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS 4 2.5 mL in 1 BOTTLE, GLASS This package is contained within the BOX (63047-0002-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/11/2010

Labeler — MACAU-UNION PHARMACEUTICAL LTD (448605614)

Establishment
Name	Address	ID/FEI	Operations
MACAU-UNION PHARMACEUTICAL LTD		448605614	manufacture (63047-0002)

Establishment
Name	Address	ID/FEI	Operations
HOE HIN PAK FAH YEOW MANUFACTORY LTD		686212961	manufacture (63047-0002)

Revised: 03/2019 MACAU-UNION PHARMACEUTICAL LTD