Active Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Indications:

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

For external use only.

Avoid contact with the eyes

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 doctor.

Do not apply to wounds or damaged skin. Do not bandage tightly.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Propylene Glycol, Glycerin, Glyceryl Stearate, Acrylamide Sodium Acrylate Copolymer, Arnica Montana Flower Extract, Cetyl Alcohol, PEG-100 Stearate, Mineral Oil, Ethoxydiglycol, Boswellia Serrata Extract, Dimethicone, Butyrospermum Parkii (Shea Butter), Fragrance (Parfum), Diazolidinyl Urea, Methylparaben, Trideceth-6, Disodium EDTA, Propylparaben, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Dimethyl Sulfone, Choline Bitartrate, Pyridoxine, Glucosamine Sulfate, Camphor, Cetyl Myristoleate, Triethanolamine

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Worldwide Cosmetics, Inc.

Eternal Spirit Beauty Painless Pain Relieving Cream

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ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0223
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.13 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
TEA TREE OIL (UNII: VIF565UC2G)
CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
PYRIDOXINE (UNII: KV2JZ1BI6Z)
TROLAMINE (UNII: 9O3K93S3TK)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0223-3	118 mL in 1 JAR; Type 0: Not a Combination Product	01/29/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	01/29/2016

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0223) , manufacture(58443-0223) , label(58443-0223) , analysis(58443-0223)