HAND SANITIZER- isopropyl alcohol gel 
Guangzhou Coral Industrial 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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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. Isopropyl 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. Carbomer (0.4% v/v).
  3. Triethanolamine (0.2% v/v).
  4. Sterile distilled water or boiled cold water.

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)

Isopropyl Alcohol 75% 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

water, carbomer, triethanolamine, Aloe Vera Leaf Extract, shea butter, vitamin E, Parfum.

Package Label - Principal Display Panel

2 mL NDC:78520-001-01 2mL Label
5 mL NDC:78520-001-02 5mL Label

10 mL NDC:78520-001-03 10mL Label
30 mL NDC:78520-001-04 30mL Label
50 mL NDC:78520-001-05 50mL Label
60 mL NDC:78520-001-06 60mL Label
80 mL NDC:78520-001-07 80mL Label
100 mL NDC:78520-001-08 100mL Label
120 mL NDC:78520-001-09 120mL Label

250 mL NDC:78520-001-10 250mL Label

300 mL NDC:78520-001-11 300mL Label

500 mL NDC:78520-001-12 500mL Label

1000 mL NDC:78520-001-13 1000mL Label

2000 mL NDC:78520-001-14 2000mL Label

5000 mL NDC:78520-001-15 5000mL Label

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78520-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 980 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
SHEA BUTTER (UNII: K49155WL9Y) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.37 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78520-001-012 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
2NDC:78520-001-025 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
3NDC:78520-001-0310 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
4NDC:78520-001-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
5NDC:78520-001-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
6NDC:78520-001-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
7NDC:78520-001-0780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
8NDC:78520-001-09120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
9NDC:78520-001-08100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
10NDC:78520-001-10250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
11NDC:78520-001-11300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
12NDC:78520-001-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
13NDC:78520-001-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
14NDC:78520-001-142000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
15NDC:78520-001-155000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
Labeler - Guangzhou Coral Industrial Co., Ltd. (550442587)
Registrant - Guangzhou Coral Industrial Co., Ltd. (550442587)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Coral Industrial Co., Ltd.550442587manufacture(78520-001)

Revised: 6/2020
Document Id: a7defe38-5731-f41b-e053-2995a90a1a39
Set id: a7debe03-0b63-2edf-e053-2a95a90a5336
Version: 1
Effective Time: 20200612
 
Guangzhou Coral Industrial Co., Ltd.