ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING CREAM- menthol cream

Eternal Spirit Beauty by

Drug Labeling and Warnings

Eternal Spirit Beauty by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WARNINGS

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.

INACTIVE INGREDIENT

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

Questions or Comments?

Worldwide Cosmetics, Inc.

Eternal Spirit Beauty Painless Pain Relieving Cream

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

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