INSTANT HAND SANITIZER- hand sanitizer gel 
Whealth Lohmann Centralin (GZ) 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 66% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

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

carbomer, fragrance, glycerin, purified water USP, triethanolamine.

Package Label - Principal Display Panel

520 mL NDC: 77976-001-95 Package LabelPackage Label

INSTANT HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77976-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL343.2 mL  in 520 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.104 mL  in 520 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.884 mL  in 520 mL
GLYCERIN (UNII: PDC6A3C0OX) 5.2 mL  in 520 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) 1.3 mL  in 520 mL
WATER (UNII: 059QF0KO0R) 169.312 mL  in 520 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77976-001-95520 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/28/2020
Labeler - Whealth Lohmann Centralin (GZ) Co., Ltd (545350568)
Registrant - Whealth Lohmann Centralin (GZ) Co., Ltd. (545350568)
Establishment
NameAddressID/FEIBusiness Operations
Whealth Lohmann Centralin (GZ) Co., Ltd.545350568manufacture(77976-001)

Revised: 7/2020
Document Id: aa13cecd-965a-8059-e053-2995a90a7ff8
Set id: a6b3c882-3f3c-558d-e053-2995a90a0b86
Version: 2
Effective Time: 20200710
 
Whealth Lohmann Centralin (GZ) Co., Ltd