HAND SANITIZER- hand sanitizer gel 
Taizhou Huangyan Delishi Daily Necessity 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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HAND SANITIZER

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire and flame.

Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

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

Do not use

Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

For external use only. Flammable. Keep away from fire and flame.

Stop use and ask a doctor if irritation or redness develops and 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 with product. briskly rub hands together until dry.

Supervise children under 6 years in the use of this product.

Other information

Store at 20°C to 25°C (68°to 77°F )

May discolor certain fabrics.

Inactive ingredients

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Aloe Barbadensis Leaf Juice.

Package Label - Principal Display Panel

60.

500

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76681-002
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76681-002-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:76681-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Taizhou Huangyan Delishi Daily Necessity Co., Ltd. (527795950)
Establishment
NameAddressID/FEIBusiness Operations
Taizhou Huangyan Delishi Daily Necessity Co., Ltd.527795950manufacture(76681-002)

Revised: 7/2020
Document Id: a9fa68ac-3144-6080-e053-2a95a90a4efc
Set id: a9fa6ebf-e44d-39d8-e053-2995a90aacba
Version: 1
Effective Time: 20200708
 
Taizhou Huangyan Delishi Daily Necessity Co., Ltd.