BYD CARE HAND SANITIZER XD-A04- alcohol gel

BYD CARE Hand Sanitizer XD-A04 by

Drug Labeling and Warnings

BYD CARE Hand Sanitizer XD-A04 by is a Otc medication manufactured, distributed, or labeled by Shanwei BYD Industrial Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Distributed by Global Healthcare Product Solutions, LLC

1 (800) 293-2886

Manufactured by:

Shanwei BYD Industrial Co., Ltd.

Shanwei High-Tech Development Zone, Shanwei, China

Tel: +86-755-89888888

Website: www.byd.com

Active Ingredient:

Alcohol 72% (V/V)

Purpose:

Antiseptic

Uses:

To Help decrease germs on the skin that could cause disease. Recommended for repeated use.

Warnings:

For external use only: hands

Flammable, Keep away from fire or flame.

When using this product:

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
• Do not inhale or ingest.
• Use with caution if allergic.
  

When using this product:

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
• Do not inhale or ingest.
• Use with caution if allergic.
  

Stop use and ask a doctor if:

• Irritation or redness develops.
• Condition persists for more than 72 hours.
  

Keep out of reach of children:

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

Directions:

• Wet hands thoroughly without wiping until they are dry.
• For children under 6, use only under adult supervision.
• Not recommended for infants.
  

Other information:

• After unseal, tighten the cap and use product within the validity period.
• After use, seal and keep away from light and moisture.
• Store in a cool and dry place. Do not store above 37 oC (98.6 oF).
  

Inactive ingredients:

Arcylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanol, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Tocopheryl Acetate, Water

Package Label - Principal Display Panel

500 mL NDC: 73818-100-01

INGREDIENTS AND APPEARANCE

BYD CARE HAND SANITIZER XD-A04 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73818-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.8 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.15 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	21.9 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	1 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.05 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)	0.3 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	3.8 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73818-100-01	500 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/08/2020

Labeler - Shanwei BYD Industrial Co Ltd (552102846)

Registrant - Shanwei BYD Industrial Co Ltd (552102846)

Establishment
Name	Address	ID/FEI	Business Operations
Shanwei BYD Industrial Co Ltd		552102846	manufacture(73818-100) , label(73818-100) , pack(73818-100)