LUSTI THERAPEUTIC ICE ANALGESIC RUB- menthol, camphor gel

Lusti Therapeutic Ice Analgesic Rub by

Drug Labeling and Warnings

Lusti Therapeutic Ice Analgesic Rub by is a Otc medication manufactured, distributed, or labeled by New Life Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%                                                 Camphor 3.1%                                                               

OTC - PURPOSE SECTION

Topical Analgesic. Temporarily relieves the minor aches and paiins associated with simple backache, arthritis, sprains, strains and bruises.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin.  Do not use with a heating pad.  Do not use on a child under 12 years of age with arthritis-like conditions.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

OTC - WHEN USING SECTION

Avoid contact with eyes or mucous membranes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use of this product and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again or excessive skin irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS SECTION

Apply liberally to painful area and massage until gel is absorbed into the skin.  Repeat three to four times daily.

INACTIVE INGREDIENT SECTION

Inactive ingredients:  Water (Aqua), Propylene Glycol, Mineral Oil, Carbomer, Triethanolamine, Methylparaben, Propylparaben, DMDM Hydantoin, Blue 1

OTC - QUESTIONS SECTION

Questions or comments: www.jflabs.comJF LABS, INC. Chicago, Illinois 60629

PACKAGE LABEL.

BONUS SIZE

Lusti

PROFESSIONAL

Therapeutic ICE

Analgesic Rub

NET WT. 10 OZ. e 284g

Deep Penetrating

Greaseless Pain Relief

Fast relief from minor

arthritis, backache, muscle,

and joint pain

INGREDIENTS AND APPEARANCE

LUSTI THERAPEUTIC ICE ANALGESIC RUB  
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49681-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	.015 g  in 1 g
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET)	Camphor (synthetic)	.031 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Mineral Oil (UNII: T5L8T28FGP)
Carbomer 934 (UNII: Z135WT9208)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Dmdm Hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49681-010-10	284 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/24/2010

Labeler - JF Labs, Inc. (047821728)

Establishment
Name	Address	ID/FEI	Business Operations
JF Labs, Inc.		047821728	MANUFACTURE