ANTIBACTERIAL HAND SANITIZER- ethyl alcohol liquid

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Royal Deluxe Accessories Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• store at a temperature below 110°F.(43°C).
• may discolor some fabrics.

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77043-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77043-166-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2020
2	NDC: 77043-166-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2020

Labeler - Royal Deluxe Accessories Llc (831333054)