Pain Relief Liquid Roller

Pain Relief Liquid Roller
SPL v4
SPL
SPL Set ID b6c3d6eb-b485-33b8-e053-2a95a90a41e1
Route
TOPICAL
Published
Effective Date 2020-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.5 g) Menthol
Inactive Ingredients
Trifolium Pratense Flower Ginger Salix Alba Bark Ethylhexylglycerin Phenoxyethanol Chamaemelum Nobile Flower Oil Water Eucalyptus Oil Fd&c Blue No. 1 Glycerin Aloe Vera Leaf Isopropyl Alcohol Indian Frankincense Cannabis Sativa Seed Echinacea Angustifolia Arnica Montana Flower Paprika Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol Lemon Oil Turmeric Tea Tree Oil Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-18

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, Anthemis Nobilis (Roman Chamomile) Flower Oil, Arnica Montana (Arnica) Flower Extract, Boswellia Serrata (Frankincense) Extract, Cannabis Sativa (Hemp) Extract, Capsicum Annuum (Paprika) Extract, Citrus Limon (Lemon) Peel Oil, Curcuma Longa (Tumeric) Root Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Trifolium Pratense (Clover) Flower Extract, Water, Zingiber Officinale (Ginger) Root Extract.

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, Anthemis Nobilis (Roman Chamomile) Flower Oil, Arnica Montana (Arnica) Flower Extract, Boswellia Serrata (Frankincense) Extract, Cannabis Sativa (Hemp) Extract, Capsicum Annuum (Paprika) Extract, Citrus Limon (Lemon) Peel Oil, Curcuma Longa (Tumeric) Root Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Trifolium Pratense (Clover) Flower Extract, Water, Zingiber Officinale (Ginger) Root Extract.

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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