SANAMAX MENTHOL PAIN RELIEF CREAM CBD- menthol cream

SanaMax Menthol Pain Relief Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients  Menthol 4%

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, 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

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

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INGREDIENTS AND APPEARANCE

SANAMAX MENTHOL PAIN RELIEF CREAM  CBD
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72425-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CANNABIDIOL (UNII: 19GBJ60SN5)
YLANG-YLANG OIL (UNII: 8YOY78GNNX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE OIL, COLD PRESSED (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 STEARATE CITRATE (UNII: WH8T92A065)
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72425-210-03	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/31/2022

Labeler - SanaMax Plus LLC (081260808)