WHITE FLOWER ANALGESIC BALM- camphor, menthol, 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.

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DRUG FACTS

Active ingredients

Camphor 6%

Menthol 15%

Methyl salicylate 40%

Purpose
External analgesic
External analgesic
External analgesic

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children to avoid accidental poisoning

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients Eucalyptus oil, lavender oil and peppermint oil.

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

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

Warnings

For external use only

WHITE FLOWER ANALGESIC BALM

NDC 48256-0002-1

0.676 fl oz (20 ml)

20 ml box

WHITE FLOWER ANALGESIC BALM 
camphor, menthol, methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63047-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE40.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63047-0002-11 in 1 BOX10/01/2018
120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:63047-0002-21 in 1 BOX10/01/2018
210 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:63047-0002-31 in 1 BOX10/01/2018
35 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4NDC:63047-0002-41 in 1 BOX10/01/2018
42.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/11/2010
Labeler - MACAU-UNION PHARMACEUTICAL LTD (448605614)
Establishment
NameAddressID/FEIBusiness Operations
MACAU-UNION PHARMACEUTICAL LTD448605614manufacture(63047-0002)
Establishment
NameAddressID/FEIBusiness Operations
HOE HIN PAK FAH YEOW MANUFACTORY LTD686212961manufacture(63047-0002)

Revised: 3/2019
Document Id: 83cdccad-32b8-213a-e053-2991aa0a8f24
Set id: c1632cd8-fe9a-408e-8624-d98efe3c4815
Version: 3
Effective Time: 20190311
 
MACAU-UNION PHARMACEUTICAL LTD