SOLGREAT- alcohol gel 
PANATURAL USA, INC.

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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Active Ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

aminomethyl propanol, carbomer, glycerin, hydrogen peroxide, purified water USP, tocopheryl acetate.

Package Label - Principal Display Panel

60 mL

60 mL

237 mL

237 mL

500 mL

500 mL

1000 mL

1000 mL

3785 mL

3785 mL

1000000 mL

1000000 mL

SOLGREAT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73913-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73913-008-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
2NDC:73913-008-02237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
3NDC:73913-008-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
4NDC:73913-008-041000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
5NDC:73913-008-053785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
6NDC:73913-008-061000000 mL in 1 TANK; Type 0: Not a Combination Product06/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - PANATURAL USA, INC. (029572239)

Revised: 6/2020
Document Id: 241d00e5-5c3a-4d3f-bb18-4777d0fcefcc
Set id: 8b9395fe-4083-4b47-994f-8a2b753f1824
Version: 1
Effective Time: 20200608
 
PANATURAL USA, INC.