ELGIN PAIN RELIEF- menthol gel

Elgin Pain Relief by

Drug Labeling and Warnings

Elgin Pain Relief by is a Otc medication manufactured, distributed, or labeled by Eco-Logics, Inc., Elginex Corporation, Natural Essentials,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC-ACTIVE INGREDIENT SECTION

Active Ingedients Purpose

Menthol USP 3.5%................... Topical Analgesic

PURPOSE

Warnings

For External Use only.

OTC ASK DOCTOR

Ask a doctor before use if you have : Sensitive skin.

When Using this Product:

Avoid contact with the eyes or mucous membranes

Do not apply to wounds or damaged skin.

Do not use with other ointments, creams sprays or limiments.

Do not apply to irritated skin or if excessive irritation develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device

Stop Use and Ask A Doctor If;

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breast feeding:

Ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison control Center immediately.

Other Information:

Store in a cool dry place with lid closed tightly.

Inactive Ingredients:

Aqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.

Dosage and Administration

Directions:

Adults and children 2 years of age and older

Apply to painful muscles and joints. Genthly massage thoroughly into affected area.

Repeat as necessary but not more than 4 times daily.

USES

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELGIN PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30056-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30056-004-28	3780 g in 1 JUG; Type 0: Not a Combination Product	07/11/2016
2	NDC: 30056-004-32	877 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/11/2016

Labeler - Eco-Logics, Inc. (047667022)

Registrant - Elginex Corporation (005142799)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials,Inc.		947484713	manufacture(30056-004)