PAINZAWAY PAIN RELIEVING GEL- 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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Painzaway Pain Relieving Gel

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

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

PainzAway®

PAIN RELIEVING GEL

NET WT. 5 OZ.

label

PAINZAWAY PAIN RELIEVING GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
TEA LEAF OIL (UNII: VC855RRT77)  
IMIDUREA (UNII: M629807ATL)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
EMU OIL (UNII: 344821WD61)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10578-135-0557 g in 1 JAR; Type 0: Not a Combination Product04/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/19/2022
Labeler - Indiana Botanic Gardens (005421771)
Registrant - Indiana Botanic Gardens (005421771)
Establishment
NameAddressID/FEIBusiness Operations
Indiana Botanic Gardens005421771manufacture(10578-135)

Revised: 4/2022
Document Id: dba1d268-ebac-0ac7-e053-2a95a90ad4b6
Set id: dba1d268-ebab-0ac7-e053-2a95a90ad4b6
Version: 1
Effective Time: 20220401
 
Indiana Botanic Gardens