Golden Cup Balm 1950: Package Insert and Label Information

GOLDEN CUP BALM 1950- methyl salicylate, menthol and camphor (synthetic) ointment
Golden Cup Pharmaceutical Co., 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.

Druf Facts

Active ingredients

Methyl salicylate 15%

Menthol 12%

Camphor 10%

Purpose

External analgesic

Use

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

When using this product

  • use only as directed.
  • avoid contact with the eyes.
  • do not apply to wounds or damaged skin,
  • do not bandage tightly.

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • excessive irritation of the skin develops.

Keep out of reach of children

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

Directions

  • adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 3 years of age: consult a doctor.

Other information

Store below 86°F (30°C)

Inactive ingredients

Cajuput oil, Cinnamon oil, Clove oil, D&C Yellow No.11, Eucalyptus oil, Hard paraffin, Liquid paraffin, Peppermint oil, White soft paraffin

Package Labeling:

Label
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Label2
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Label3
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GOLDEN CUP BALM 1950
methyl salicylate, menthol, camphor (synthetic) ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73791-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 150 mg in 1 g
MENTHOL (MENTHOL) MENTHOL 120 mg in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CAJUPUT OIL
CINNAMON OIL
CLOVE OIL
D&C YELLOW NO. 11
EUCALYPTUS OIL
PARAFFIN
MINERAL OIL
PEPPERMINT OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73791-001-22 1 JAR in 1 BOX contains a JAR
1 22 g in 1 JAR This package is contained within the BOX (73791-001-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/25/2020
Labeler — Golden Cup Pharmaceutical Co., Ltd. (659853253)

Revised: 03/2020 Golden Cup Pharmaceutical Co., Ltd.

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