CROWN SOLUTIONS INSTANT HAND SANITIZER GEL- alcohol gel 
RAF, LLC

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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Crown Solutions Instant Hand Sanitizer Gel

DRUG FACTS

Ethyl Alcohol 62% (v/v)

PURPOSE

Antibacterial

USES:

Hand sanitizer to reduce bacteria on the skin

WARNINGS:

For external use only 

Flammable: Keep away from fire or flame

when using this product.

Avoid contact with eyes. In case of eye contact, flush with water.

Stop use and if

irritation and redness develop and persist for more than 3 days.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

DIRECTIONS:

Apply a small amount unto hands, rub in hands thoroughly until dry. No rinsing required

OTHER INFORMATION :

Do not store above 120 degrees F

INACTIVE INGREDIENTS:

water, acrylates/SC 10-30 cross polymer, glycerin, propylene glycol, aloe barbadensis leaf juice, ammomethyl propanol, fragrance 

Package Labeling: 118 ml

Bottle

box

Package Labeling: 236 ml

Bottle2

box

Package Labeling: 946 ml

Bottle3

box

Package Labeling: 3784 ml

Bottle4

box

Package Labeling: 946000 ml

Bottle5

box

CROWN SOLUTIONS INSTANT HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81570-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81570-001-0124 in 1 BOX09/04/2021
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:81570-001-0224 in 1 BOX09/04/2021
2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:81570-001-034 in 1 BOX09/04/2021
3946 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:81570-001-044 in 1 BOX09/04/2021
43784 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:81570-001-051 in 1 BOX09/04/2021
5946000 mL in 1 TANK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/04/2021
Labeler - RAF, LLC (007736291)

Revised: 9/2021
Document Id: cbf7e393-eb90-b854-e053-2a95a90a9e0e
Set id: 0403be03-d72e-4ec5-8fd8-0a0deb9cefbf
Version: 1
Effective Time: 20210914
 
RAF, LLC