DR. BLUE- menthol gel 
Indiana Botanic Gardens

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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Dr. Blue

Drug Facts


Active Ingredient

Menthol 4.6%

Purpose

topical analgesic gel

Uses

■ temporary relief of minor aches and pains of muscles & joints associated with

simple backache, arthritis, bruises and sprains ■ provides cooling pain relief

Warnings

For external use only

When using this product

■ Do not heat ■ Do not microwave ■ Do not use near open flame ■ Do not add to hot

water or any container when heating water. May cause splattering and result in burns. ■ Avoid

contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

■ See the important warnings under "when using this product"

■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: consult physician.

Other Information:

Use only if seal is unbroken.

Inactive Ingredients

Aloe Vera Concentrate, Carbopol-940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SDA Alcohol 39B, Triethanolamine, Water

Questions?

1-800-644-8327

Manufactured by Indiana Botanic Gardens, Inc

3401 W. 37th Ave. Hobart, IN 46342

website: www.botanicchoice.com

Pain Relieving Gel

Dr. Blue

For temporary relief of minor aches and pains of muscles and joints.

image of label
DR. BLUE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.89 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EMU OIL (UNII: 344821WD61)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
IMIDUREA (UNII: M629807ATL)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10578-035-0371 g in 1 JAR
2NDC:10578-035-04142 g in 1 JAR
3NDC:10578-035-0557 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2003
Labeler - Indiana Botanic Gardens (005421771)
Establishment
NameAddressID/FEIBusiness Operations
Indiana Botanic Gardens005421771manufacture(10578-035)

Revised: 9/2014
Document Id: 62d551fd-f9f3-4b00-a07a-db2556661003
Set id: 444f8116-da9e-40c9-9a5f-81adf0b08a2c
Version: 2
Effective Time: 20140926
 
Indiana Botanic Gardens