Sanamax Menthol Pain Relief Cream

Sanamax Menthol Pain Relief Cream
SPL v3
SPL
SPL Set ID 21242f22-b2b1-42e1-8b1e-d5e32f49febf
Route
TOPICAL
Published
Effective Date 2023-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.0 g)
Inactive Ingredients
Benzyl Alcohol Cannabidiol Ylang-ylang Oil Medium-chain Triglycerides Caprylyl Glycol Cetostearyl Alcohol Chamomile Flower Oil Bergamot Oil Orange Oil, Cold Pressed Crambe Hispanica Subsp. Abyssinica Seed Oil Cymbopogon Schoenanthus Oil Ethylhexylglycerin Eucalyptus Oil Glycerin Glyceryl Stearate Citrate Helichrysum Italicum Flower Oil Lavender Oil Lecithin, Sunflower Peppermint Oil Spearmint Oil Polyoxyl 40 Hydrogenated Castor Oil Polyethylene Glycol 300 Phenoxyethanol Pogostemon Cablin Leaf Oil Polyglyceryl-3 Ricinoleate Clary Sage Oil Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-31

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses : temporarily relieves the minor aches and pains of muscles and

joints associated with:  ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and Administration

Directions

■ use only as directed ■ adults and children 12 years of age and

older: apply to affected area 3 to 4 times daily

■ children under 12 years of age: ask a doctor before use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children to avoid accidental ingestion.

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

Section 50566-9

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ skin irritation occurs

Section 50567-7

When using this product ■ avoid contact with eyes or mucous membrane

■ do not bandage tightly

Section 50569-3

Ask a doctor before use if you have redness over the affected area.

Section 50570-1

Do not use: ■ on wounds, damaged, broken, or irritated skin

■ with a heating pad  ■ on a child under 12 years of age with

arthritis-like conditions.

Section 51727-6

Inactive Ingredients:

Benzyl Alcohol, Cannabidiol, Cananga Odorata (Ylang Ylang) Flower Oil, Caprylic/

Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Matricaria)

Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium

Dulcis (Orange) Peel Oil, Crambe Abyssinica Seed Oil, Cymbopogon Schoenanthus

Oil, Ethyl- hexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate,

Helichrysum Italicum Flower Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin,

Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, PEG-40

Hydrogenated Castor Oil, PEG-6, Phenoxyethanol, Pogostemon Cablin (Patchouli)

Oil, Polyglyceryl-3 Ricinoleate, Salvia Sclarea (Clary Sage) Oil, Sodium Acrylate/

Sodium Acryloyldimethyl Taurate Copolymer, Water/Aqua

Section 55105-1

Purpose  Topical analgesic

Section 55106-9

Active Ingredients  Menthol 4%

Section 60561-8

Other information :

■ Store at 68° to 77°F (20° to 25°C)

Labeling

SanaMax

MENTHOL PAIN RELIEF CREAM

CBD 300mg

3.4 FL OZ (100mL)

Distributed by:

SanaMax Plus, LLC

McAllen, TX 78501

Questions or Comments? sanamaxplus.com

res


Structured Label Content

Indications and Usage (34067-9)

Uses : temporarily relieves the minor aches and pains of muscles and

joints associated with:  ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and Administration (34068-7)

Directions

■ use only as directed ■ adults and children 12 years of age and

older: apply to affected area 3 to 4 times daily

■ children under 12 years of age: ask a doctor before use

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ skin irritation occurs

Section 50567-7 (50567-7)

When using this product ■ avoid contact with eyes or mucous membrane

■ do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

Section 50570-1 (50570-1)

Do not use: ■ on wounds, damaged, broken, or irritated skin

■ with a heating pad  ■ on a child under 12 years of age with

arthritis-like conditions.

Section 51727-6 (51727-6)

Inactive Ingredients:

Benzyl Alcohol, Cannabidiol, Cananga Odorata (Ylang Ylang) Flower Oil, Caprylic/

Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Matricaria)

Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium

Dulcis (Orange) Peel Oil, Crambe Abyssinica Seed Oil, Cymbopogon Schoenanthus

Oil, Ethyl- hexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate,

Helichrysum Italicum Flower Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin,

Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, PEG-40

Hydrogenated Castor Oil, PEG-6, Phenoxyethanol, Pogostemon Cablin (Patchouli)

Oil, Polyglyceryl-3 Ricinoleate, Salvia Sclarea (Clary Sage) Oil, Sodium Acrylate/

Sodium Acryloyldimethyl Taurate Copolymer, Water/Aqua

Section 55105-1 (55105-1)

Purpose  Topical analgesic

Section 55106-9 (55106-9)

Active Ingredients  Menthol 4%

Section 60561-8 (60561-8)

Other information :

■ Store at 68° to 77°F (20° to 25°C)

Labeling

SanaMax

MENTHOL PAIN RELIEF CREAM

CBD 300mg

3.4 FL OZ (100mL)

Distributed by:

SanaMax Plus, LLC

McAllen, TX 78501

Questions or Comments? sanamaxplus.com

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)