RINSE-FREE HAND SANITIZER- hand sanitizer gel 
Guangzhou Gotdya Fine Chemical 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)

Ethyl alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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 now.

Directions

  • Place enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children should be supervised when using hand sanitizer.

Other information

  • Store between 15-40C (59-104F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aminomethyl propanol, carbomer, propylene glycol, sterile distilled water.

Package Label - Principal Display Panel

60 mL NDC: 76591-401-01 Package LabelPackage Label

Package Label - Principal Display Panel

236 mL NDC: 76591-401-02 Package LabelPackage Label

Package Label - Principal Display Panel

473 mL NDC: 76591-401-03 Package LabelPackage Label

Package Label - Principal Display Panel

500 mL NDC: 76591-401-04 Package LabelPackage LabelPackage Label

Package Label - Principal Display Panel

1000 mL NDC: 76591-401-05 Package LabelPackage LabelPackage Label

Package Label - Principal Display Panel

3785 mL NDC: 76591-401-06 Package LabelPackage Label

RINSE-FREE HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76591-401
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.07 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 24.2 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.23 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76591-401-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/2020
2NDC:76591-401-02236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/2020
3NDC:76591-401-03473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/2020
4NDC:76591-401-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/2020
5NDC:76591-401-051000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/2020
6NDC:76591-401-063785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/2020
Labeler - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)
Registrant - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.551470189manufacture(76591-401)

Revised: 10/2021
Document Id: ced5258a-0dc6-2b98-e053-2a95a90a74c6
Set id: ac1e45d5-bc3d-1506-e053-2a95a90af566
Version: 3
Effective Time: 20211020
 
Guangzhou Gotdya Fine Chemical Co., Ltd.