Herbal Balm

Herbal Balm
SPL v2
SPL
SPL Set ID 09b3b86d-3434-428b-b0a8-e8dfd7c0b52a
Route
TOPICAL
Published
Effective Date 2022-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (156 mg) Salicylic Acid (207 mg) Camphor (synthetic) (31 mg)
Inactive Ingredients
Eucalyptus Oil Lavender Oil Petrolatum White Wax

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

Methyl Salicylate 20.7% Menthol 15.6% Camphor 3.1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Methyl Salicylate 20.7% Menthol 15.6% Camphor 3.1%

Uses

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

  • arthritis
  • strains
  • bruises
  • sprains
  • simple backache
Section 42229-5

If pregnant, ask a health professional before use.

Section 50565-1

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.

Section 50566-9

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
Section 50567-7

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
Section 50570-1

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

Warnings

For external use only

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.

Active Ingredients

Methyl Salicylate 20.7%

Menthol 15.6%

Camphor 3.1%

Questions Or Comments?

Tel: 714-531-2020

Web: tnduocthao.com

Principal Display Panel


Structured Label Content

Uses

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

  • arthritis
  • strains
  • bruises
  • sprains
  • simple backache
Section 42229-5 (42229-5)

If pregnant, ask a health professional before use.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50570-1 (50570-1)

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

Purpose

External analgesic

Warnings

For external use only

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.

Active Ingredients

Methyl Salicylate 20.7%

Menthol 15.6%

Camphor 3.1%

Questions Or Comments? (Questions or Comments?)

Tel: 714-531-2020

Web: tnduocthao.com

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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