COLORROSE HAND SANITIZER- alcohol gel 
Zhejiang Cheerflor Cosmetics 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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Colorrose Hand Sanitizer

Drug Facts

[Active ingredient]

Alcohol 75% v/v

[Purpose]

Sterilization

[Inactive ingredients]

Aqua, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Triethanolamine, Glycerin, Propylene Glycol, Aloe Vera Extract.

[Use]

Hand disinfection. Helps reduce bacteria on the skin and kills most common germs that may cause illness.

[Directions]

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

[Warnings]

  1. For external use only.
  2. Flammable. Keep away from fire or flame.

3.When using this product

do not use in or near the eyes .In case of contact, rinse eyes thoroughly with water. 

Stop use and ask a doctor

if irritation on rash appears and lasts.

4.Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

5.Store below 110 degrees F [43 degrees C].

Package and Labeling 30ml

Label.

Package and Labeling 50ml

Label2

Package and Labeling 1000ml

Label8

Package Labeling:78163-001-03

Bottle60

Package Labeling:78163-001-04

Bottle100

Package Labeling:78163-001-05

Bottle240

Package Labeling:78163-001-06

Bottle300

Package Labeling:78163-001-07

Bottle500

COLORROSE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78163-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78163-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
2NDC:78163-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
3NDC:78163-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
4NDC:78163-001-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
5NDC:78163-001-05240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
6NDC:78163-001-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
7NDC:78163-001-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
8NDC:78163-001-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/20/2020
Labeler - Zhejiang Cheerflor Cosmetics Co., Ltd. (529325329)

Revised: 6/2020
Document Id: a748c114-26df-1e53-e053-2a95a90a97e1
Set id: 3d946432-734f-43ea-b25c-48b15c923c27
Version: 2
Effective Time: 20200604
 
Zhejiang Cheerflor Cosmetics Co., Ltd.