Outback Pain Relief Liquid Cream

Outback Pain Relief Liquid Cream
SPL v3
SPL
SPL Set ID c238c930-2012-2d48-e053-2a95a90a8a4a
Route
TOPICAL
Published
Effective Date 2021-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (6 g) Menthol (16 g)
Inactive Ingredients
Medium-chain Triglycerides Ethylhexylglycerin Cetostearyl Alcohol Water Cetyl Alcohol Glycerin Eucalyptus Globulus Leaf Tea Tree Oil Tocopherol Vanilla Bean Cetearyl Olivate Sorbitan Olivate Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Benzyl Alcohol C13-14 Isoparaffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-13
Description

Camphor 6%, Menthol 16%

Medication Information

Warnings and Precautions

For external use only. When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

Dosage and Administration

Adults and children 12 years of age and older apply generously to the affected area not more than 4 times daily. Children under 12 years of age: ask a doctor.

Description

Camphor 6%, Menthol 16%

Section 50565-1

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

Section 51727-6

Benzyl Alcohol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, Sorbitan Olivate, Tocopherol, Vanilla Planifolia Fruit Extract, Water.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding ask a health professional.

Section 55105-1



Topical Analgesic

Section 55106-9

Camphor 6%, Menthol 16%

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older apply generously to the affected area not more than 4 times daily. Children under 12 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only. When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Benzyl Alcohol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, Sorbitan Olivate, Tocopherol, Vanilla Planifolia Fruit Extract, Water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding ask a health professional.

Section 55105-1 (55105-1)



Topical Analgesic

Section 55106-9 (55106-9)

Camphor 6%, Menthol 16%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:59.260805 · Updated: 2026-03-14T23:06:13.532900