75% ALCOHOL HAND SANITIZER- hand sanitizer solution 
Shangrao Chunyu Technology 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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Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand-washing to decrease bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame.

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.

Do not use

Stop use and ask doctor if irritation and redness develop.

Keep out of reach of children. If swallowed, get medical help or call Poison Control Center right away.

Directions

Inactive ingredients

Aminomethylpropanol, carbopol 980 polymer, glycerin, propylene glycol, sterile distilled water.

Package Label - Principal Display Panel

30mL NDC: 72922-014-01 Package LabelPackage Label

Package Label - Principal Display Panel

60 mL NDC: 72922-014-02 Package LabelPackage Label

Package Label - Principal Display Panel

​29 mL NDC: 72922-014-03 Package LabelPackage Label

75% ALCOHOL HAND SANITIZER 
hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72922-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E) 0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 23.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72922-014-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
2NDC:72922-014-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
3NDC:72922-014-0329 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2020
Labeler - Shangrao Chunyu Technology Co.,ltd. (541569308)
Registrant - Shangrao Chunyu Technology Co.,ltd. (541569308)
Establishment
NameAddressID/FEIBusiness Operations
Shangrao Chunyu Technology Co.,ltd.541569308manufacture(72922-014)

Revised: 7/2020
Document Id: a9d717fd-ea73-6af8-e053-2a95a90a0653
Set id: a95925df-bcf4-0306-e053-2a95a90accea
Version: 2
Effective Time: 20200707
 
Shangrao Chunyu Technology Co.,ltd.