HAND SANITIZER- isopropyl alcohol gel 
GUILIN LIFENG MEDICAL SUPPLIES 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 Gel

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Ethyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin (1.45% v/v).
  3. Moisture Complex.
  4. Herbal Essence (0.125% v/v).
  5. Carbopol
  6. Fragrance

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to decrease bacteria on the skin that may cause disease.

Warnings

For external use only: hands or skin surface

Flammable, keep away from fire or flame

Caution for those who are allergic to alcohol

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

Other information

Inactive ingredients

Glycerin, Moisture Complex, Herbal Essence, Carbopol, Fragrance

Package Label - Principal Display Pane

2 L label236 ml label60 ml Label

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81898-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81898-103-1060 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:81898-103-11236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:81898-103-122000 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 - GUILIN LIFENG MEDICAL SUPPLIES CO.,LTD. (546406728)
Registrant - GUILIN LIFENG MEDICAL SUPPLIES CO.,LTD. (546406728)
Establishment
NameAddressID/FEIBusiness Operations
GUILIN LIFENG MEDICAL SUPPLIES CO.,LTD.546406728manufacture(81898-103)

Revised: 5/2021
Document Id: c28f16a4-ec84-53ce-e053-2995a90a636e
Set id: c28f16a4-ec85-53ce-e053-2995a90a636e
Version: 1
Effective Time: 20210517
 
GUILIN LIFENG MEDICAL SUPPLIES CO.,LTD.