MYSTIC ESSENTIALS ORIGINAL PAIN RELIEF RUB- camphor, menthol liquid

Mystic Essentials Original Pain Relief Rub by

Drug Labeling and Warnings

Mystic Essentials Original 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 on wounds - damaged, broken, or irritated skin
• Stop use and ask doctor if condition 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

Chamomile Oil, Eucalyptus Globulus Oil, Fractionated Coconut Oil, Helichrysum Oil, Lavender Oil, Peppermint Oil, Rosemary + 1,8 Cineole Oil, Tea Tree 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

0.34 FL OZ (10ml) Carton Display Panel

INGREDIENTS AND APPEARANCE

MYSTIC ESSENTIALS ORIGINAL PAIN RELIEF RUB 
camphor, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73769-450
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)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEPPERMINT OIL (UNII: AV092KU4JH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73769-450-01	10 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/01/2024
2	NDC: 73769-450-03	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(73769-450)