PAINZAWAY PAIN RELIEVING GEL- menthol gel

Painzaway Pain Relieving Gel by

Drug Labeling and Warnings

Painzaway Pain Relieving Gel 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 a physician.

Other Information:

Use only if seal is unbroken.

Inactive Ingredients

Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SD 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

PainzAway®

PAIN RELIEVING GEL

NET WT. 5 OZ.

INGREDIENTS AND APPEARANCE

PAINZAWAY PAIN RELIEVING GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-135
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
TEA LEAF OIL (UNII: VC855RRT77)
IMIDUREA (UNII: M629807ATL)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EMU OIL (UNII: 344821WD61)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-135-05	57 g in 1 JAR; Type 0: Not a Combination Product	04/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/19/2022

Labeler - Indiana Botanic Gardens (005421771)

Registrant - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	manufacture(10578-135)