CLEACE- ethyl alcohol gel 
Nanjing Aogrand Int'l Corp

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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CLEACE

Active Ingredient

Ethyl Alcohol

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes. Do not use in ears & mouth.

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

Other information

Inactive ingredients

carbomer, triethanolamine, glycerin, water

1oz CLEACE

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2oz CLEACE

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3.4oz CLEACE

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8oz CLEACE

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10oz CLEACE

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16.9oz CLEACE

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33.8oz CLEACE

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39.9oz CLEACE

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50.7 oz CLEACE

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169.1oz CLEACE

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676.3oz CLEACE

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CLEACE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74621-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74621-002-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
2NDC:74621-002-0260 mL in 1 PACKAGE; Type 0: Not a Combination Product04/07/2020
3NDC:74621-002-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
4NDC:74621-002-04237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
5NDC:74621-002-05296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
6NDC:74621-002-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
7NDC:74621-002-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
8NDC:74621-002-081180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
9NDC:74621-002-091500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
10NDC:74621-002-105000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
11NDC:74621-002-1120000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/07/2020
Labeler - Nanjing Aogrand Int'l Corp (421353092)
Establishment
NameAddressID/FEIBusiness Operations
Nanjing Aogrand Int'l Corp421353092manufacture(74621-002)

Revised: 4/2020
Document Id: 9f432ee2-549f-4c86-9aa5-4ced447f4bf0
Set id: d9b2b5a2-380b-41d8-927b-c15fcc4a94a2
Version: 1
Effective Time: 20200407
 
Nanjing Aogrand Int'l Corp