Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID 4e9cb5aa-b0aa-4a5c-b561-cc38437758d8

Route

TOPICAL

Published

Effective Date 2010-07-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Camphor (synthetic) (5.4 g) Menthol (13 g) Salicylic Acid (35.8 g)

Inactive Ingredients

Eucalyptus Oil Lavender Oil Peppermint Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-07-30

Description

Active ingredients Camphor 5.4% Menthol 13.1% Methyl salicylate 36%

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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
children under 3 years of age and pregnant women: do not use, consult a physician
refer to the above warnings; use otherwise than as directed may be dangerous

Description

Active ingredients Camphor 5.4% Menthol 13.1% Methyl salicylate 36%

Section 44425-7

Other information

keep tightly sealed
store at or below 30º C (86º F), away from direct sunlight

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
when using for pain of arthritis:
- 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 irritated or damaged skin
on wounds
otherwise than as directed

Section 51727-6

Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.

Section 51945-4

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED NDC-48256-0011-1 0.338 fl oz (10 mL)

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also use this phone number to report serious side effects

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredients

Camphor 5.4%

Menthol 13.1%

Methyl salicylate 36%

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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
children under 3 years of age and pregnant women: do not use, consult a physician
refer to the above warnings; use otherwise than as directed may be dangerous

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep tightly sealed
store at or below 30º C (86º F), away from direct sunlight

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
when using for pain of arthritis:
- 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 irritated or damaged skin
on wounds
otherwise than as directed

Section 51727-6 (51727-6)

Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.

Section 51945-4 (51945-4)

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED NDC-48256-0011-1 0.338 fl oz (10 mL)

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also use this phone number to report serious side effects

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 5.4%

Menthol 13.1%

Methyl salicylate 36%

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": "5.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "35.8", "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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently. children under 3 years of age and pregnant women: do not use, consult a physician refer to the above warnings; use otherwise than as directed may be dangerous", "34071-1": "Warnings For external use only", "44425-7": "Other information keep tightly sealed store at or below 30º C (86º F), away from direct sunlight", "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 when using for pain of arthritis: 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 irritated or damaged skin on wounds otherwise than as directed", "51727-6": "Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.", "51945-4": "WHITE FLOWER ANALGESIC BALM FLORAL SCENTED NDC-48256-0011-1 0.338 fl oz (10 mL)", "53413-1": "Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also use this phone number to report serious side effects", "55105-1": "Purpose External analgesic", "55106-9": "Active ingredients Camphor 5.4% Menthol 13.1% Methyl salicylate 36%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:18.354038 · Updated: 2026-03-14T23:01:21.342577