Dr. Blue by Indiana Botanic Gardens DR. BLUE- menthol gel

Dr. Blue by

Drug Labeling and Warnings

Dr. Blue by is a Otc medication manufactured, distributed, or labeled by Indiana Botanic Gardens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 4.6%

Purpose

topical analgesic

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

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE. HOBART, IN 46342

Website: BotanicChoice.com

PRINCIPAL DISPLAY PANEL

Pain Relieving Gel

Dr. Blue

Bend Free All Day

INGREDIENTS AND APPEARANCE

DR. BLUE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.58 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
IMIDUREA (UNII: M629807ATL)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
EMU OIL (UNII: 344821WD61)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLYCERIN (UNII: PDC6A3C0OX)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-131-02	57 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2016
2	NDC: 10578-131-05	142 g in 1 JAR; Type 0: Not a Combination Product	11/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2016

Labeler - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	manufacture(10578-131)