MAGNIFICENT MENTHOL COOLING PAIN CREAM- menthol topical analgesic cream

MagNificent Menthol Cooling Pain Cream by

Drug Labeling and Warnings

MagNificent Menthol Cooling Pain Cream by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Warnings

For external use only

When using this product

Do not bandage tightly

• avoid contact with eyes
• do not apply to wounds or damaged skin
• do not use with heating pads or other heating devices.

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

Keep out of reach of children

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

Directions

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physicial or occupational therapist

• children under 12 years of age: contact physical or occupational therapist

Inactive Ingredients:

Butyrospermum Parkii (Shea

Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol

(CBD) Extract, Cetearyl Alcohol,

Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera

(Coconut) Oil, Deionized Water, Emulsifying Wax,

Hamamelis Virginiana (Witch Hazel) Magnesium Chloride,

Mangifera Indica (Mango) Seed Butter,

Mentha piperita (Peppermint) Leaf Oil, Olea Europaea

(Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Xanthan Gum

INDICATIONS & USAGE

Uses

For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAGNIFICENT MENTHOL COOLING PAIN CREAM 
menthol topical analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-421
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCONUT OIL (UNII: Q9L0O73W7L)
CANNABIDIOL (UNII: 19GBJ60SN5)
OLIVE OIL (UNII: 6UYK2W1W1E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CORN OIL (UNII: 8470G57WFM)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
LAURETH-7 (UNII: Z95S6G8201)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
WHITE WAX (UNII: 7G1J5DA97F)
WITCH HAZEL (UNII: 101I4J0U34)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PEPPERMINT OIL (UNII: AV092KU4JH)
GRAPEFRUIT OIL (UNII: YR377U58W9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-421-01	112 g in 1 JAR; Type 0: Not a Combination Product	12/06/2018
2	NDC: 76348-421-02	112 g in 1 BOX; Type 0: Not a Combination Product	12/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/06/2018

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-421)