Pain Relief Liquid Roller

Pain Relief Liquid Roller
SPL v3
SPL
SPL Set ID b4cd4fed-e8c8-db85-e053-2995a90a708b
Route
TOPICAL
Published
Effective Date 2020-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.5 g) Menthol
Inactive Ingredients
Ethylhexylglycerin Phenoxyethanol Water Eucalyptus Oil Fd&c Blue No. 1 Glycerin Aloe Vera Leaf Isopropyl Alcohol Ilex Paraguariensis Leaf Calendula Arvensis Leaf Matricaria Chamomilla Flowering Top Oil Echinacea Angustifolia Arnica Montana Flower Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol Green Tea Leaf Juniper Berry

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-30

Description

Camphor 3.5%, Menthol 3.5%


Medication Information

Warnings and Precautions

For external use only. Flammable--Do not use while smoking or near heat or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. 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 to the affected area not more than 3 to 4 times daily.

Description

Camphor 3.5%, Menthol 3.5%

Section 50565-1

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

Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aminomethyl Propanol, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Juniperus Communis (Juniper) Fruit Extract, Phenoxyethanol, 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 3.5%, Menthol 3.5%


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 to the affected area not more than 3 to 4 times daily.

Warnings and Precautions (34071-1)

For external use only. Flammable--Do not use while smoking or near heat or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. 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)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aminomethyl Propanol, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Juniperus Communis (Juniper) Fruit Extract, Phenoxyethanol, 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 3.5%, Menthol 3.5%


Advanced Ingredient Data


Raw Label Data

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