La Flecha Japonesa

SPL v5

SPL

SPL Set ID 08819ad0-97c2-49bd-b923-535b94a27167

Route

TOPICAL

Published

Effective Date 2022-02-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (105 mg)

Inactive Ingredients

Cajuput Oil Clove Oil Peppermint Oil Eucalyptus Oil Juniper Berry Oil Menthol Mineral Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-02-21

Description

Active Ingredients Purpose Methyl Salicate 10.5%..............................................................External Analgesic

Purpose

External Analgesic

Medication Information

Warnings and Precautions

For external use only. Do not use otherwise than as directed.

Purpose

External Analgesic

Description

Active Ingredients Purpose Methyl Salicate 10.5%..............................................................External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthrits
strains
sprains

Section 51945-4

Purpose

External Analgesic

Questions?

1-800-560-5223 M-F 9 AM to 4 PM Eastern.

Directions

use only as directed

adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Do Not Use

with a bandage
on wounds or damage skin
with a heating pad
on a child under 12 years of age
over extensive areas of the body
on irritated skin

Drug Facts

Active Ingredients Purpose

Methyl Salicate 10.5%..............................................................External Analgesic

Other Information

store at 15° to 25° C (59° to 77° F)

Inactive Ingredients

cajeput oil, clove oil, essential oil of peppermint, eucalyptus oil, juniper, menthol, white mineral oil.

When Using This Product

avoid contact with eyes or mucuos membranes
do not bandage

Stop Use and Ask A Doctor If

condition worsen or symptoms persists for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

If Pregnant Or Breast Feeding

ask a health professional before use

Ask A Doctor Before Use If You Have

redness over the affected area

Keep Out of the Reach of Children to Avoid Accidental Poisoning.

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthrits
strains
sprains

Warnings and Precautions (34071-1)

For external use only. Do not use otherwise than as directed.

Section 51945-4 (51945-4)

Purpose

External Analgesic

Questions?

1-800-560-5223 M-F 9 AM to 4 PM Eastern.

Directions

use only as directed

adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Do Not Use (Do not use )

with a bandage
on wounds or damage skin
with a heating pad
on a child under 12 years of age
over extensive areas of the body
on irritated skin

Drug Facts

Active Ingredients Purpose

Methyl Salicate 10.5%..............................................................External Analgesic

Other Information (Other information )

store at 15° to 25° C (59° to 77° F)

Inactive Ingredients

cajeput oil, clove oil, essential oil of peppermint, eucalyptus oil, juniper, menthol, white mineral oil.

When Using This Product (When using this product)

avoid contact with eyes or mucuos membranes
do not bandage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if )

condition worsen or symptoms persists for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

If Pregnant Or Breast Feeding (if pregnant or breast-feeding )

ask a health professional before use

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have )

redness over the affected area

Keep Out of the Reach of Children to Avoid Accidental Poisoning. (Keep out of the reach of children to avoid accidental poisoning.)

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CAJUPUT OIL", "unii": "J3TO6BUQ37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JUNIPER BERRY OIL", "unii": "SZH16H44UY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "105", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses ": "For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthrits strains sprains", "34071-1": "For external use only. Do not use otherwise than as directed.", "Purpose ": "External Analgesic ", "Questions?": "1-800-560-5223 M-F 9 AM to 4 PM Eastern.", "Directions ": "use only as directed adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily children under 12 years of age: ask a doctor", "Do not use ": "with a bandage on wounds or damage skin with a heating pad on a child under 12 years of age over extensive areas of the body on irritated skin ", "Drug Facts ": "Active Ingredients Purpose Methyl Salicate 10.5%..............................................................External Analgesic", "Other information ": "store at 15° to 25° C (59° to 77° F)", "Inactive Ingredients": "cajeput oil, clove oil, essential oil of peppermint, eucalyptus oil, juniper, menthol, white mineral oil.", "When using this product": "avoid contact with eyes or mucuos membranes do not bandage", "Stop use and ask a doctor if ": "condition worsen or symptoms persists for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs ", "if pregnant or breast-feeding ": "ask a health professional before use", "Ask a doctor before use if you have ": "redness over the affected area", "Keep out of the reach of children to avoid accidental poisoning.": "If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:35.727112 · Updated: 2026-03-14T23:09:26.831955