BLUE GEL PAIN RELIEVING- menthol gel 
Rugby Laboratories

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.

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Drug Facts

Active ingredient  

Menthol 2%

Purpose

Analgesic

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● arthritis ● simple backache ● strains ● sprains

● provides cooling penetrating relief

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding

ask a health professional before use

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

ammonium hydroxide, carbopol 934P, cupric sulfate monohydrate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate heptyhydrate, sodium hydroxide, thymol, water

Questions or comments?

call 1-800-645-2158

Additional Information Listed on Other Panels

Distributed by:

Rugby Laboratories

Livonia, MI 48150 USA

Blue Gel

External Analgesic

Pain Relieving Gel

Principal Display

Blue Gel

 

BLUE GEL  PAIN RELIEVING
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-2302
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .02 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
CUPRIC SULFATE (UNII: LRX7AJ16DT)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
THYMOL (UNII: 3J50XA376E)  
WATER (UNII: 059QF0KO0R)  
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-2302-59 227 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: a4e2f2f5-533e-4bc5-87ba-80838d193bd5
Set id: d4e432b1-8997-412f-9357-c7b6757852e5
Version: 1
Effective Time: 20130114
 
Rugby Laboratories