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

WHEN USING

Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken, or irritated skin.
A transient burning sensation or redness may occur upon application but generally disappears in several days.
If you experience an allergic reaction, discontinue use, and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

STOP USE

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

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 of age

Apply a small amount on the affected area.
Massage in 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: do not use, consult a doctor.

INACTIVE INGREDIENT

Isopropyl Myristate, Fragrance (Parfum), Limonene, Pimpinella Anisum (Aniseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Oil, Ocimum Basilicum (Basil) Oil.

NATUREANCE - MIRACLE OIL

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 Drug	M017	09/19/2020

Labeler - EROS GLOBAL CORP (117597821)