HERBAL BALM- methyl salicylate, menthol and cream

Herbal Balm by

Drug Labeling and Warnings

Herbal Balm by is a Otc medication manufactured, distributed, or labeled by Big 5 Nutrition LLC, Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Methyl Salicylate 20.7%

Menthol 15.6%

Camphor 3.1%

Purpose

External analgesic

Uses

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

• arthritis
• strains
• bruises
• sprains
• simple backache

Warnings

For external use only

Do not use

• on wounds

• irritated or damaged skin

• sensative skin

• with a heating pad

• if pregnant

• with, or as the same time as, other external analgesic products

• if allergic to aspirin or salicylates

• if allergic to any ingredients of this prodcut

When using this product

• avoid contact with eyes
• do not bandage tightly
• do not apply to wounds or damaged skin
• do not use 1 hour before or after bathing

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
• redness is present
• side effects occur

If pregnant, ask a health professional before use.

Keep out of reach of childrento avoid accidental poisoning

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use otherwise than as directed.

Directions

• Apply to the affected area. Rub well on affected area.
• Repeat 2 times daily.
•  Children under 2 years of age: Do not use or consult a doctor.

Other Information

• Store at room temperature, 20 to 25°C (68 to 77°F)

Other Ingredients

Eucalyptus Oil, Lavender Oil, Vaseline, White beeswax.

Questions or Comments?

Tel: 714-531-2020

Web: tnduocthao.com

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INGREDIENTS AND APPEARANCE

HERBAL BALM 
methyl salicylate, menthol and cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	156 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	207 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	31 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0007-1	50 g in 1 JAR; Type 0: Not a Combination Product	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2022

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.		656348265	manufacture(82198-0007)