DR. BLUE PAINZAWAY PAIN RELIEVING ROLL-ON- menthol lotion

Drug Labeling and Warnings

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 a physician.

Other Information:

Use only if seal is unbroken.

Inactive Ingredients

alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, aqua / water / eau, citric acid, dimethyl sulfone, emu oil, ethylhexylglycerin, FD&C Blue No. 1, glucosamine sulfate, glycerin, potassium sorbate, propylene glycol, raspberry ketone, rosa canina (rosehip) seed oil, sclerotium gum, sodium benzoate, t-butyl alcohol, tocopherol.

Questions?

1-800-644-8327

SPL UNCLASSIFIED SECTION

MANUFACTURED BY
INDIANA BOTANIC GARDENS, INC.
3401 W. 37TH AVE., HOBART, IN 46342
Website: BotanicChoice.com

C-125423

PRINCIPAL DISPLAY PANEL

Fast Acting

Dr. Blue PainZaway Pain Relieving Roll-On

4.6% Menthol Lotion

Cooling Relief

Net Wt. 3 oz. (85 g).

INGREDIENTS AND APPEARANCE

DR. BLUE PAINZAWAY PAIN RELIEVING ROLL-ON 
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
T-BUTYL ALCOHOL (UNII: MD83SFE959)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
TOCOPHEROL (UNII: R0ZB2556P8)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID (UNII: 2968PHW8QP)
RASPBERRY KETONE (UNII: 7QY1MH15BG)
WATER (UNII: 059QF0KO0R)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-136-03	85 g in 1 CYLINDER; Type 0: Not a Combination Product	04/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/06/2026

Labeler - Indiana Botanic Gardens (005421771)

Registrant - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	manufacture(10578-136)