Lusti Therapeutic Ice Analgesic Rub

Dosage form: gel
Ingredients: Menthol .015g in 1g, Camphor (synthetic) .031g in 1g
Labeler: JF Labs, Inc.
NDC Code: 49681-010

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Lusti Therapeutic Ice Analgesic Rub

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

LUSTI THERAPEUTIC ICE ANALGESIC RUB  
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol.015 g  in 1 g
Camphor (synthetic) (Camphor (synthetic)) Camphor (synthetic).031 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Mineral Oil 
Carbomer 934 
Methylparaben 
Propylparaben 
Dmdm Hydantoin 
Packaging
#Item CodePackage Description
1NDC:49681-010-10284 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/24/2010
Labeler - JF Labs, Inc. (047821728)
Establishment
NameAddressID/FEIOperations
JF Labs, Inc.047821728MANUFACTURE

Revised: 04/2010
 
JF Labs, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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