HAND SANITIZER- alcohol gel 
Markwins Beauty Products, 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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Smackers Purifying Pals Hand Sanitizer Cotton Candy Clouds

Active Ingredient

Ethyl alcohol 63%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only - do not use on damaged or broken skin

When using this product

keep out of eyes, ears, and mouth. in case of contact, rinse eyes thoroughly with water. avoid contact with broken skin. do not inhale or ingest

Stop use and ask a doctor

if irritation or rash occurs and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

Store below 86F (30C). avoid freezing and excessive heat 104F (40C). may discolor certain fabrics or surfaces.

Inactive ingredients

water/eau, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, sodium hyaluronate, aminomethyl propanol, trehalose, biosaccharide gum-1, glycereth-26, tocopheryl acetate, flavor/aroma, red 40 (ci 16035), yellow 5 (ci 19140).

Directions

place enough product on hands to cover hands thoroughly. rub hands together until dry. for children under 6 years of age, use only under adult supervision. not recommended for infants.

PDP

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
TREHALOSE (UNII: B8WCK70T7I)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
GLYCERETH-26 (UNII: NNE56F2N14)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12027-300-0125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Markwins Beauty Products, Inc. (135407760)

Revised: 6/2020
Document Id: a83cf094-7a0a-5e4e-e053-2a95a90ab713
Set id: a83cf094-7a09-5e4e-e053-2a95a90ab713
Version: 1
Effective Time: 20200616
 
Markwins Beauty Products, Inc.