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SPL v4

SPL

SPL Set ID 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5

Routes

TOPICAL PERCUTANEOUS TRANSDERMAL

Published

Effective Date 2024-12-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (86.24 mg) Menthol (166.92 mg) Salicylic Acid (278.2 mg)

Inactive Ingredients

Mineral Oil Aluminum Silicate Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-05-17

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Uses

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

arthritis
simple backache
strains
bruises
sprains

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

clean and dry affected area
remove patch from film
apply to affected area not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Do Not Use

on wounds or damaged skin
with a heating pad
if you are allergic to any ingredients of this product

Allergy Alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Other Information

avoid storing product in direct sunlight
protect product from excessive moisture

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, aluminum silicate, terpene resin, titanium dioxide

Questions Or Comments?

Toll free 1-800-826-8861 www.salonpas.u

Principal Display Panel

OTC topical analgesics in patch category*

WORLDS'S BRAND NO.1

Hisamitsu

NDC#46581-210-06

for temporary relief of minor aches and pains

BACKACHE

SORE SHOULDER

STIFF NECK

JOINT PAIN

Salonpas

Pain Relieving Patch

LARGE

APPLY FOR 8 HOURS

6 PATCHES

5.67" X 3.62" (14.4 X 9.2cm)

MADE IN JAPAN

When Using This Product

use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly

Stop Use and Ask A Doctor If

rash, itching or excessive skin irritation develops
contisions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

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

arthritis
simple backache
strains
bruises
sprains

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

clean and dry affected area
remove patch from film
apply to affected area not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

on wounds or damaged skin
with a heating pad
if you are allergic to any ingredients of this product

Allergy Alert: (Allergy alert:)

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Other Information (Other information)

avoid storing product in direct sunlight
protect product from excessive moisture

Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients (Inactive ingredients)

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, aluminum silicate, terpene resin, titanium dioxide

Questions Or Comments? (Questions or comments?)

Toll free 1-800-826-8861 www.salonpas.u

Principal Display Panel

OTC topical analgesics in patch category*

WORLDS'S BRAND NO.1

Hisamitsu

NDC#46581-210-06

for temporary relief of minor aches and pains

BACKACHE

SORE SHOULDER

STIFF NECK

JOINT PAIN

Salonpas

Pain Relieving Patch

LARGE

APPLY FOR 8 HOURS

6 PATCHES

5.67" X 3.62" (14.4 X 9.2cm)

MADE IN JAPAN

When Using This Product (When using this product)

use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly

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

rash, itching or excessive skin irritation develops
contisions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "86.24", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "166.92", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "278.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM SILICATE", "unii": "T1FAD4SS2M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains", "Purpose": "Topical analgesic", "Warnings": "For external use only", "Directions": "Adults and children 12 years of age and over: clean and dry affected area remove patch from film apply to affected area not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age: consult a doctor", "Do not use": "on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product", "Allergy alert:": "If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.", "Other information": "avoid storing product in direct sunlight protect product from excessive moisture", "Active ingredients": "Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%", "Inactive ingredients": "mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, aluminum silicate, terpene resin, titanium dioxide", "Questions or comments?": "Toll free 1-800-826-8861 www.salonpas.u", "Principal Display Panel": "OTC topical analgesics in patch category* WORLDS'S BRAND NO.1 Hisamitsu NDC#46581-210-06 for temporary relief of minor aches and pains BACKACHE SORE SHOULDER STIFF NECK JOINT PAIN Salonpas Pain Relieving Patch LARGE APPLY FOR 8 HOURS 6 PATCHES 5.67" X 3.62" (14.4 X 9.2cm) MADE IN JAPAN", "When using this product": "use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly", "Stop use and ask a doctor if": "rash, itching or excessive skin irritation develops contisions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:35.983871 · Updated: 2026-03-14T23:05:28.061539