Golden Cup Balm 1950 by Golden Cup Pharmaceutical Co., Ltd. Golden Cup Balm 1950

Golden Cup Balm 1950 by

Drug Labeling and Warnings

Golden Cup Balm 1950 by is a Otc medication manufactured, distributed, or labeled by Golden Cup Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GOLDEN CUP BALM 1950- methyl salicylate, menthol, 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.

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Golden Cup Balm 1950

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:

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	120 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
CINNAMON OIL (UNII: E5GY4I6YCZ)
CLOVE OIL (UNII: 578389D6D0)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PARAFFIN (UNII: I9O0E3H2ZE)
MINERAL OIL (UNII: T5L8T28FGP)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73791-001-22	1 in 1 BOX	08/25/2020	12/15/2022
1		22 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/25/2020	12/15/2022

Labeler - Golden Cup Pharmaceutical Co., Ltd. (659853253)

Revised: 12/2022

Document Id: efdf596d-a5d2-2fb0-e053-2a95a90a613b

34390-5

Set id: e561b934-094f-4ff6-9f6d-ccc4731c2845

Version: 2

Effective Time: 20221215