NATUREANCE MIRACLE- menthol oil

NATUREANCE MIRACLE by

Drug Labeling and Warnings

NATUREANCE MIRACLE by is a Otc medication manufactured, distributed, or labeled by EROS GLOBAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 8%

PURPOSE

Topical Analgesic

USES:

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS

For external use only.

WHEN USING

Avoid contact with the eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not apply to the irritated skin or if excessive irritation develops.
Do not bandage.
Do not use with heating pad or device.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

OTHER SAFETY INFORMATION

Keep away from fire or flame.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and Children over 12 years:

Apply a small amount on the area to be.
Massaged in a circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: Consult physician.

OTHER INFORMATION:

Store in a cool dry place with lid closed tightly.

INACTIVE INGREDIENT

Isopropyl Myristate, Parfum, Limonene.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATUREANCE MIRACLE 
menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80465-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80465-008-01	28.4 g in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/19/2020

Labeler - EROS GLOBAL CORP (117597821)