COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF- menthol gel

COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF by

Drug Labeling and Warnings

COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

NATURAL Menthol USP 3.7%

PURPOSE:

TOPICAL ANALGESIC

*USES:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

WARNINGS:

Use only as directed.

• For external use only
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
• Avoid contact with eyes or mucous membranes

• Pregnancy - Breast Feeding Warning:
• If pregnant or breast feeding, ask a physician before use.

• Do not use with other topical products
• Do not use with heating devices
• Do not use on open wounds, damaged or irritated skin
• Keep away from excessive heat or open flame.

• KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN.
• Accidental ingestion: Seek professional help and contact Poison Control immediately.

DIRECTIONS:

Adults and children 12 years and older

• Apply and gently massage painful joints and/or muscles.
• Repeat as needed no more than 4 times a day.
• Wash hands after each use with cold water

OTHER:

Store in cool dry area - close cap tight

INACTIVE INGREDIENTS:

†Aloe Barbadensis Leaf Extract, †Arnica Montana Extract, Camphor, Carbomer, Ethylhexylglycerin, †llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.

†This symbol before the ingredient indicates certified organic:

Principal Display Panel - Cold Leaf Nutrition Container Label

MUSCLE & JOINT PAIN RELIEF*

Leaf Cold Nutrition

ALOE AND ARNICA, VITAMIN E AND TEA TREE OIL
GREASELESS VANISHING SCENT ROLL ON FORMULA

NO PARABENS NO SYNTHETIC FRAGRANCE NO SULFATES
NO PARAFFINS NO DEA NO PETROLATUM NO MINERAL OIL
NO ANIMAL TESTING

89 mL (3 fl oz)

INGREDIENTS AND APPEARANCE

COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	37 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-114-13	89 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/27/2018

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-114)