ANTIBACTERIAL HAND SANITIZER- ethyl alcohol liquid 
Royal Deluxe Accessories 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.

----------

Antibacterial Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses 

• To help 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. If contact occurs, rinse with water.


Stop use and ask a doctor if skin irritation or redness develops.

Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision.

• not recommended for infants.

Other information:

Inactive ingredients​:

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine,  Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E),  FD&C Yellow No.5 (Tartrazine), FD&C Blue No.1.

KILLS GERMS WITHOUT WATER

Effective at eliminating over 99.99% of many common harmful germs and bacteria.

Distributed by:Royal Deluxe Accessories,LLC

Made in China / Fabrique'en Chine / Hecho en China

Packaging

untitled

ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77043-166
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77043-166-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
2NDC:77043-166-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/2020
Labeler - Royal Deluxe Accessories Llc (831333054)

Revised: 4/2020
Document Id: 53ec7985-0d14-4533-8774-60f2663e5b88
Set id: 6a2ec96d-1ba5-4cad-9f6d-e5c7848511d6
Version: 1
Effective Time: 20200428
 
Royal Deluxe Accessories Llc