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

•: on wounds or damaged skin

When using this product

•: avoid contact with the eyes
•: do not bandage tightly

Stop use and ask a doctor if

•: condition worsens
•: symptoms last more than 7 days or clear up and occur again within a few days

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

•: clean and dry skin
•: may be used with wet or dry dandages or ice packs
•: adults & children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
•: children under 2 years: ask a doctor

Other information

•: store at room temperature
•: keep container tightly closed
•: keep away from heat or open flame

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	.02 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-2302-59	227 g in 1 JAR; Type 0: Not a Combination Product	10/29/2012	04/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/29/2012	04/30/2018

Labeler - Rugby Laboratories (191427277)

Revised: 9/2019

Document Id: 7b46d414-ca8e-43ab-8cd6-8939548647b4

Set id: d4e432b1-8997-412f-9357-c7b6757852e5

Version: 2

Effective Time: 20190904

Rugby Laboratories