PAIN RELIEF CREAM- menthol cream

Pain Relief Cream by

Drug Labeling and Warnings

Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by SanaMax Plus LLC, Identipak, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients  Menthol 1.25%

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.

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.

ASK DOCTOR

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

WHEN USING

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

■ do not bandage tightly

STOP USE

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

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

INGREDIENTS AND APPEARANCE

PAIN RELIEF CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72425-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE OIL (UNII: AKN3KSD11B)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72425-201-02	1 in 1 BOX	12/02/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/02/2019

Labeler - SanaMax Plus LLC (081260808)

Registrant - Identipak, Inc. (942862350)

Establishment
Name	Address	ID/FEI	Business Operations
Identipak, Inc.		942862350	manufacture(72425-201)