HAND SANITIZER- alcohol gel 
GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED 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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Water 24.19%, Alcohol 70%, Carbomer 0.4%, Triethanolamine 0.4%, Glycerin 2%, Propylene Glycol 0.5%

,Aloe Barbadensis Leaf Juice 2%, Tocopheryl Acetate 0.5%, Fragrance 0.01%

Active Ingredient(s)

Alcohol Denat 70.0%
Purpose: Antimicrobial

Purpose

Antiseptic, Hand Sanitizer

Use

To decrease bacteria on the skin. Recommended for repeated use.

Warnings

Supervision required for children under the age of 10. For external use only. Flammable. Keep away from heat and flames.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 for 10 seconds - wait for air dry.

Other information

Store in a cool dry place at room temperature.

Inactive ingredients

water, carbomer, triethanoglamine, glycerine, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

Package Label - Principal Display Panel

480 mL NDC: 78098-001-02 480ml-2

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78098-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.01 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78098-002-01480 mL in 1 BOTTLE, PUMP; 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 - GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD (554457375)
Registrant - GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD (554457375)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD554457375manufacture(78098-002)

Revised: 5/2020
Document Id: a6000c2d-cea4-8164-e053-2a95a90a7da7
Set id: a6000c2d-ceb2-8164-e053-2a95a90a7da7
Version: 1
Effective Time: 20200519
 
GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD