MYSTIC ESSENTIALS ZEN PAIN RELIEF RUB- camphor, menthol liquid

Mystic Essentials Zen Pain Relief Rub by

Drug Labeling and Warnings

Mystic Essentials Zen Pain Relief Rub by is a Otc medication manufactured, distributed, or labeled by NATURE'S FUSIONS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

USES

For the temporary relief of minor aches and pain associated with *backache *arthritis *muscle strains *strains *bruises

ACTIVE INGREDIENT

Camphor 0.5% - Topical Analgesic (pain relief)

Menthol 3.00% - Topical Analgesic (pain relief)

WARNINGS

• For External Use Only
• Do not use onwounds - damaged, broken, or irritated skin
• Stop use and ask doctor ifcondition worsens * irritation develops *redness is present *symptoms persist for more than 7 days or clear up and occur again within a few days

______________________________

When using this product

• Use only as directed
• Avoid contact with eyes or mucous membranes
• Do not bandage tightly or use with a heating pad.
• ______________________________

If Pregnant or breast feeding, ask a health professional before use.

INDICATIONS & USAGE

Directions

Adults and children 12 years and older: Apply to the affected area no more than 3 to 4 times daily. Children under the age of 12: Ask a doctor.

OTHER SAFETY INFORMATION

Other Information

• Keep container tightly closed
• Store at room temperature (68°-77° F)

INACTIVE INGREDIENT

Inactive Ingredients

Basil Linalool Oil, Eucalyptus Oil, Evening Primrose Oil, Frankincense Oil, Fractionated Coconut Oil, Ginger Root Oil, Lavender Oil, Lemongrass Oil, Peppermint Oil, Rosemary + 1,8 Cineole Oil, Wintergreen Oil

OTHER SAFETY INFORMATION

Questions?Call (800) 352-7032

KEEP OUT OF REACH OF CHILDREN

Keep our of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years and older: Apply to the affected area no more than 3 to 4 times daily. Children under the age of 12: Ask a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYSTIC ESSENTIALS ZEN PAIN RELIEF RUB 
camphor, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73769-451
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY OIL (UNII: 8LGU7VM393)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEPPERMINT OIL (UNII: AV092KU4JH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GINGER OIL (UNII: SAS9Z1SVUK)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
BASIL OIL (UNII: Z129UMU8LE)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73769-451-01	10 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/01/2024
2	NDC: 73769-451-03	30 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/01/2024

Labeler - NATURE'S FUSIONS, LLC (051472644)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE'S FUSIONS, LLC		051472644	manufacture(73769-451)