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Drug Facts
Pain Relief Cream
FDA Label NDC 72425-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanamax Plus Llc for the product Pain Relief Cream (NDC 72425-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
res
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