ANTIBACTERIAL HAND SANITIZER- alcohol gel 
Suavecito,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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Antibacterial Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use in the eyes. In case of contact, rinse eyes with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Keep Out of reach of children. If swallowed get medical help or contact poison control center right away.

Directions

Other Information

Inactive Ingredients

Water, Propylene Glycol, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Peg-60, Almond Glycerides, Aloe Barbadensis Leaf Juice, Triisopropanolamine, Fragrance

Dist. by:
Suavecito, Inc.
Santa Ana, Calif. 92703

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

SUAVECITO®

ANTIBACTERIAL
HAND SANITIZER

KILLS 99.99% OF ALL GERMS.
WITH ALOE VERA & VITAMIN E.

8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74866-714
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
Propylene Glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
aloe vera leaf (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
triisopropanolamine (UNII: W9EN9DLM98)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74866-714-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E04/15/2020
Labeler - Suavecito,Inc. (078681797)
Establishment
NameAddressID/FEIBusiness Operations
BMC 1092, Inc. dba Solo Laboratories, Inc.078831987MANUFACTURE(74866-714) , PACK(74866-714)
Establishment
NameAddressID/FEIBusiness Operations
Suavecito078681797LABEL(74866-714) , PACK(74866-714)

Revised: 4/2020
Document Id: 3e5cb601-fe14-4ffa-a23b-dfa09da42bdb
Set id: b381ab32-8f15-4d3b-b1fc-23bb62a36c16
Version: 1
Effective Time: 20200415
 
Suavecito,Inc.