El Bálsamo De Tigre

El Bálsamo De Tigre
SPL v2
SPL
SPL Set ID de245261-83a5-4aba-8d7e-470ff0cf845c
Route
TOPICAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g) Menthol (3.5 g)
Inactive Ingredients
White Petrolatum Eucalyptus Oil Clove Oil D&c Green No. 6 D&c Red No. 17 D&c Yellow No. 11

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-01-08 Until 2026-06-30

Description

Methyl Salicylate 10% Menthol 3.5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 10% Menthol 3.5%

Uses:

*Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

Section 42229-5

MADE IN USA

SATISFACTION GUARANTEED QUALITY

*These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure or prevent any disease.

Distributed by:

OTC & Quality Distribution

Orlando, FL 32837

InfoLine:

1-877-325-7887

www.otcqualitydistribution.com

Section 50565-1

Keep out of reach of children.

If swallowed get medical help. Do not bandage.

Packaging

Warnings:

For external use only.

Do not Use:

• If allergic to salicylates (including aspirin) without consulting a physician.

• On open wounds, damage or irritated skin, immediately after or before taking a shower.

Stop use and ask a Doctor: If conditions worsen, symptoms persist or skin irritations occurs.

When using this product: Avoid contact with eyes, lips and any mucous membranes.

Drug Facts

Directions:

Clean area before use.

Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use.

Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks.

Children under 12 years: Consult a Physician before use.

Active Ingredients

Methyl Salicylate 10%

Menthol 3.5%

Other Information:

Store at 15-25° C (59-77° F)

Inactive Ingredients:

White Petrolatum, Eucalyptus oil, Clove Oil, Dark Brown MX-486


Structured Label Content

Uses:

*Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

Section 42229-5 (42229-5)

MADE IN USA

SATISFACTION GUARANTEED QUALITY

*These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure or prevent any disease.

Distributed by:

OTC & Quality Distribution

Orlando, FL 32837

InfoLine:

1-877-325-7887

www.otcqualitydistribution.com

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed get medical help. Do not bandage.

Purpose

Topical Analgesic

Packaging

Warnings:

For external use only.

Do not Use:

• If allergic to salicylates (including aspirin) without consulting a physician.

• On open wounds, damage or irritated skin, immediately after or before taking a shower.

Stop use and ask a Doctor: If conditions worsen, symptoms persist or skin irritations occurs.

When using this product: Avoid contact with eyes, lips and any mucous membranes.

Drug Facts

Directions:

Clean area before use.

Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use.

Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks.

Children under 12 years: Consult a Physician before use.

Active Ingredients

Methyl Salicylate 10%

Menthol 3.5%

Other Information:

Store at 15-25° C (59-77° F)

Inactive Ingredients:

White Petrolatum, Eucalyptus oil, Clove Oil, Dark Brown MX-486


Advanced Ingredient Data


Raw Label Data

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