White flower analgesic balm oil

Otc - active ingredient section

Active ingredients

Camphor 6%

Menthol 15%

Methyl salicylate 40%

Otc - purpose section

Purpose

External analgesic


Otc - do not use section


Do not use

  • on wounds
  • on irritated or damaged skin
  • on the face
  • otherwise than as directed

Otc - when using section

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

Otc - keep out of reach of children section

Keep out of reach of children to avoid accidental poisoning

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

Storage and handling section

Other information

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

Inactive ingredient section

Inactive ingredients

Eucalyptus oil, lavender oil and peppermint oil.

Indications & usage section

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Ingredients and appearance - Product information

White flower analgesic balm oil- Camphor, menthol and methyl salicylate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 48256-0002
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Camphor (synthetic) ( UNII: 5TJD82A1ET)( Camphor (synthetic) - UNII: 5TJD82A1ET ) 6 gin 100 mL
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 14.5 gin 100 mL
Methyl salicylate ( UNII: LAV5U5022Y)( Salicylic acid - UNII: O414PZ4LPZ ) 40.02 gin 100 mL

Inactive Ingredients

Ingredient Name Code
Eucalyptus oil ( UNII: 2R04ONI662)
Lavender oil ( UNII: ZBP1YXW0H8)
Peppermint oil ( UNII: AV092KU4JH)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 48256-0002-1 20mL in 1 BOTTLE, GLASS 2018/10/01
2 NDC: 48256-0002-2 10mL in 1 BOTTLE, GLASS 2018/10/01
3 NDC: 48256-0002-4 2.5mL in 1 BOTTLE, GLASS 2018/10/01
4 NDC: 48256-0002-3 5mL in 1 BOTTLE, GLASS 2018/10/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA 2018/10/01

Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD( 686359001)

Establishment

Name ID/FEI Business Operations
HOE HIN PAK FAH YEOW MANUFACTORY LTD 686359001 repack( 48256-0002)