FDA Label for Pain Relief Cream

View Indications, Usage & Precautions

Pain Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Sanamax Plus Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



Active Ingredients  Menthol 1.25%


Otc - Purpose



Purpose  Topical analgesic


Indications & Usage



Uses: temporarily relieves the minor aches and pains of muscles and
joints associated with:  ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains


Warnings



Warnings
For external use only.


Otc - Do Not Use



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.


Otc - Ask Doctor



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


Otc - When Using



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

■ do not bandage tightly


Otc - Stop Use



Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days
■ skin irritation occurs


Otc - Keep Out Of Reach Of Children



Keep out of reach of children to avoid accidental ingestion.

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


Dosage & 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


Other Safety Information



Other information:

■ Store at 68° to 77°F (20° to 25°C)


Inactive Ingredient



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


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

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