Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID f3e3b8b5-b12b-49ac-9318-b0c358b136e9

Route

TOPICAL

Published

Effective Date 2024-09-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Camphor (synthetic) (6 g) Menthol (14.5 g) Salicylic Acid (40.02 g)

Inactive Ingredients

Eucalyptus Oil Lavender Oil Peppermint Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-06-11

Description

Active ingredients Camphor 6% Menthol 15% Methyl salicylate 40%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

simple backache
arthritis
strains
bruises
sprains

Dosage and Administration

Directions

Adults and children 3 years of age and older: Apply a few drops then gently rub into the affected area not more than 4 times daily.
For younger children, consult your doctor.

Description

Active ingredients Camphor 6% Menthol 15% Methyl salicylate 40%

Section 44425-7

Other information

keep container tightly closed
store at 15º to 30ºC (59º to 86ºF)

Section 50565-1

Keep out of reach of children to avoid accidental poisoning

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

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
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
pain persists for more than 10 days
redness is present
- in conditions affecting children under 12 years of age

Section 50567-7

When using this product

avoid contact with the eyes or mucous membranes
do not bandage tightly

Section 50570-1

Do not use

on wounds
on irritated or damaged skin
on the face
otherwise than as directed

Section 51727-6

Inactive ingredients

Eucalyptus oil, lavender oil and peppermint oil.

Section 51945-4

White Flower Analgesic Balm NDC-48256-0002 0.676 fl oz (20mL)

Section 53413-1

Questions? +1-626-823-9933 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredients

Camphor 6%

Menthol 15%

Methyl salicylate 40%

Structured Label Content

Indications and Usage (34067-9)

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

simple backache
arthritis
strains
bruises
sprains

Dosage and Administration (34068-7)

Directions

Adults and children 3 years of age and older: Apply a few drops then gently rub into the affected area not more than 4 times daily.
For younger children, consult your doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed
store at 15º to 30ºC (59º to 86ºF)

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning

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

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
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
pain persists for more than 10 days
redness is present
- in conditions affecting children under 12 years of age

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes or mucous membranes
do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds
on irritated or damaged skin
on the face
otherwise than as directed

Section 51727-6 (51727-6)

Inactive ingredients

Eucalyptus oil, lavender oil and peppermint oil.

Section 51945-4 (51945-4)

White Flower Analgesic Balm NDC-48256-0002 0.676 fl oz (20mL)

Section 53413-1 (53413-1)

Questions? +1-626-823-9933 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 6%

Menthol 15%

Methyl salicylate 40%

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": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "14.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "40.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of minor aches and pains of muscles and joints due to simple backache arthritis strains bruises sprains", "34068-7": "Directions Adults and children 3 years of age and older: Apply a few drops then gently rub into the affected area not more than 4 times daily. For younger children, consult your doctor.", "34071-1": "Warnings For external use only", "44425-7": "Other information keep container tightly closed store at 15º to 30ºC (59º to 86ºF)", "50565-1": "Keep out of reach of children to avoid accidental poisoning If swallowed, get medical help or contact a Poison Control Center right away.", "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 nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age", "50567-7": "When using this product avoid contact with the eyes or mucous membranes do not bandage tightly", "50570-1": "Do not use on wounds on irritated or damaged skin on the face otherwise than as directed", "51727-6": "Inactive ingredients Eucalyptus oil, lavender oil and peppermint oil.", "51945-4": "White Flower Analgesic Balm NDC-48256-0002 0.676 fl oz (20mL)", "53413-1": "Questions? +1-626-823-9933 M-F 9am to 5pm you may also report serious side effects to this phone number", "55105-1": "Purpose External analgesic", "55106-9": "Active ingredients Camphor 6% Menthol 15% Methyl salicylate 40%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:18.373537 · Updated: 2026-03-14T23:13:13.649161