Bt Pain Relief Balm

SPL v1

SPL

SPL Set ID 50112419-c934-4d3a-9ea6-9b089f516a6d

Route

TOPICAL

Published

Effective Date 2023-11-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (207.3 mg) Menthol (155.5 mg) Camphor, (-)- (31.1 mg)

Inactive Ingredients

Eucalyptus Oil Lavender Oil Petrolatum White Wax Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-01

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%

Section 42229-5

Distributed by:

Big 5 Nutrition LLC

Made in Taiwan

Section 50565-1

Keep out of reach of children to 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 51945-4

uses

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

strains
bruises
sprains
simple backache
travel and motion sickness
itching from insect and mosquito bites
heat stroke and dizziness

Directions

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

purpose

External Analgesic

warnings

For external use only.

Do not use

on wounds • irritated or damaged skin
sensitive 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 product

When using this product

avoid contact with the 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.

drug Facts

Other Information

Store unused products in the box
Store at room temperature, 20 to 25 ^oC (68 to 77 ^oF)

Inactive Ingredients

Cinnamomum kanehirae Hayata Essential Oil, Eucalyptus oil, Lavender oil, Vaseline, White beeswax, FD&C Yellow No. 4

active Ingredients

Methyl Salicylate 20.7%

Menthol 15.6%

Camphor 3.1%

Questions Or Comments?

www.twleaderlife.com

Structured Label Content

Section 42229-5 (42229-5)

Distributed by:

Big 5 Nutrition LLC

Made in Taiwan

Section 50565-1 (50565-1)

Keep out of reach of children to 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 51945-4 (51945-4)

uses (Uses)

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

strains
bruises
sprains
simple backache
travel and motion sickness
itching from insect and mosquito bites
heat stroke and dizziness

Directions

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

purpose (Purpose)

External Analgesic

warnings (Warnings)

For external use only.

Do not use

on wounds • irritated or damaged skin
sensitive 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 product

When using this product

avoid contact with the 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.

drug Facts (Drug Facts)

Other Information

Store unused products in the box
Store at room temperature, 20 to 25 ^oC (68 to 77 ^oF)

Inactive Ingredients

Cinnamomum kanehirae Hayata Essential Oil, Eucalyptus oil, Lavender oil, Vaseline, White beeswax, FD&C Yellow No. 4

active Ingredients (Active ingredients)

Methyl Salicylate 20.7%

Menthol 15.6%

Camphor 3.1%

Questions Or Comments? (Questions or Comments?)

www.twleaderlife.com

Advanced Ingredient Data

[{"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAVENDER OIL", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "207.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "155.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CAMPHOR, (-)-", "unii": "213N3S8275", "classCode": "ACTIB", "strengthNumerator": "31.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"42229-5": "Distributed by: Big 5 Nutrition LLC Made in Taiwan", "50565-1": "Keep out of reach of children to 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.", "Uses": "For the temporary relief of minor aches and pains of muscles due to: strains bruises sprains simple backache travel and motion sickness itching from insect and mosquito bites heat stroke and dizziness", "Directions": " Apply to the affected area. Rub well on affected area. Repeat a few times daily. Children under 2 years of age: Do not use or consult a doctor", "Purpose": "External Analgesic ", "Warnings": "For external use only. Do not use on wounds • irritated or damaged skin sensitive 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 product When using this product avoid contact with the 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.", "Other Information": "Store unused products in the box Store at room temperature, 20 to 25 o C (68 to 77 o F)", "Inactive Ingredients": "Cinnamomum kanehirae Hayata Essential Oil, Eucalyptus oil, Lavender oil, Vaseline, White beeswax, FD&C Yellow No. 4", "Active ingredients": "Methyl Salicylate 20.7% Menthol 15.6% Camphor 3.1%", "Questions or Comments?": "www.twleaderlife.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.379968 · Updated: 2026-03-14T23:02:18.218337