BYD CARE HAND SANITIZER XD-A04- alcohol gel 
Shanwei BYD Industrial Co Ltd

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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Misc.

Model: XD-A04

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 500-1

Active Ingredient:

Alcohol 72% (V/V) 500-2

Purpose:

Antiseptic 500-3

Uses:

500-4To 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. 500-5

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.
    500-6

When using this product:

  • 500-7
    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.
    500-8

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away. 500-9

Directions:

  • Wet hands thoroughly without wiping until they are dry.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
    500-10

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).
    500-11

Inactive ingredients:

Arcylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanol, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Tocopheryl Acetate, Water 500-12

Package Label - Principal Display Panel

500-13

BYD CARE HAND SANITIZER XD-A04 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73818-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73818-201-02500 mL in 1 BAG; Type 1: Convenience Kit of Co-Package06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - Shanwei BYD Industrial Co Ltd (552102846)
Registrant - Shanwei BYD Industrial Co Ltd (552102846)
Establishment
NameAddressID/FEIBusiness Operations
Shanwei BYD Industrial Co Ltd552102846manufacture(73818-201) , label(73818-201) , pack(73818-201)

Revised: 1/2022
Document Id: d581b3a3-abcf-a22f-e053-2995a90aaa7d
Set id: a75b6f73-e745-3da5-e053-2a95a90abec1
Version: 2
Effective Time: 20220113
 
Shanwei BYD Industrial Co Ltd