Sanamax Plus Pain Relief Cream

Sanamax Plus Pain Relief Cream
SPL v4
SPL
SPL Set ID fee161dc-5047-4b98-9edc-130facbc731d
Route
TOPICAL
Published
Effective Date 2023-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Benzyl Alcohol Cananga Odorata Flower Medium-chain Triglycerides Caprylyl Glycol Cetostearyl Alcohol Chamomile Flower Oil Bergamot Oil Orange Oil Crambe Hispanica Subsp. Abyssinica Seed Oil Cymbopogon Schoenanthus Oil Ethylhexylglycerin Eucalyptus Oil Glycerin Glyceryl Monostearate 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 2019-12-02

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, Cananga Odorata (Ylang

Ylang) Flower Oil, Caprylic/Capric Trigl-

yceride, 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 1.25%

Section 60561-8

Other information :

■ Store at 68° to 77°F (20° to 25°C)

Principal Display Package Labeling

SanaMax PLUS

BALANCED FORMULA

SanaMax PLUS

PAIN RELIEF CREAM

Temporary relief from backache,

minor arthritis, muscle and joint pain.

Quick Absorbing         Paraben Free

Non Staining               Non-Greasy

Non-Burning               Fast Relief

Relaxing Scent            Calming Effect

       DOCTOR RECOMMENDED

WITH 12 ESSENTIAL OILS

NET WT 1 OZ (28g)

SanaMax PLUS

PAIN RELIEF CREAM

SanaMax Plus is trusted

by medical doctors,

pharmacists, physical

therapists, chiropractors,

massage therapists,

podiatrists, and athletic

trainers. It applies easily

and penetrates quickly for

fast temporary relief from

sore muscles, backaches,

sore joints, and arthritis.

SanaMax Plus is a balanced formula that contains 12

essential oils. It is quick absorbing but is not greasy, does not

stain, has a relaxing scent, a calming effect, and does not

burn.

SanaMax Plus is not tested on animals, is made in the USA

with USP grade ingredients, is free of parabens, and

propylene glycol.

Distributed by:                        Questions or Comments

SanaMax Plus LLC                       sanamaxplus.com

McAllen, TX 78501

                      NDC 72425-201-02

8  60473 00240  2

PE 2020/013

   VER 01

BOX

TUBE

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, Cananga Odorata (Ylang

Ylang) Flower Oil, Caprylic/Capric Trigl-

yceride, 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 1.25%

Section 60561-8 (60561-8)

Other information :

■ Store at 68° to 77°F (20° to 25°C)

Principal Display Package Labeling

SanaMax PLUS

BALANCED FORMULA

SanaMax PLUS

PAIN RELIEF CREAM

Temporary relief from backache,

minor arthritis, muscle and joint pain.

Quick Absorbing         Paraben Free

Non Staining               Non-Greasy

Non-Burning               Fast Relief

Relaxing Scent            Calming Effect

       DOCTOR RECOMMENDED

WITH 12 ESSENTIAL OILS

NET WT 1 OZ (28g)

SanaMax PLUS

PAIN RELIEF CREAM

SanaMax Plus is trusted

by medical doctors,

pharmacists, physical

therapists, chiropractors,

massage therapists,

podiatrists, and athletic

trainers. It applies easily

and penetrates quickly for

fast temporary relief from

sore muscles, backaches,

sore joints, and arthritis.

SanaMax Plus is a balanced formula that contains 12

essential oils. It is quick absorbing but is not greasy, does not

stain, has a relaxing scent, a calming effect, and does not

burn.

SanaMax Plus is not tested on animals, is made in the USA

with USP grade ingredients, is free of parabens, and

propylene glycol.

Distributed by:                        Questions or Comments

SanaMax Plus LLC                       sanamaxplus.com

McAllen, TX 78501

                      NDC 72425-201-02

8  60473 00240  2

PE 2020/013

   VER 01

BOX

TUBE

res


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