NEWRAIN HAND SANITIZER- alcohol gel 
Ganzhou Olivee Cosmetic 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.

----------

OPALINE HAND SANITIZER

Drug Facts

Active ingredient

Alcohol 75% ±5%

Purpose

 Antiseptic

Use(s)

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

Warnings

For external use only.

Flammable. Keep product away from fire or flame.

When using this prouct do not use in or near the eye. In case of contact, rine eyes thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and persists.

Other Information:

store between 15-30℃ (59-86℉)

avoid freezing and excssive heat above 40℃（104℉）.

Keep out of reach of children.

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

Warning choking Hazard: Small Parts. Not intended for children under 3 years of age.

Directions

Wet hands thoroughly with product and rub hands together until dry.

Inactive ingredients

Alcohol Denat, Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Packaging

image description

NEWRAIN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56136-312-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
2NDC:56136-312-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:56136-312-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/30/2020
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Registrant - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-312)

Revised: 4/2020
Document Id: 17d0d3be-f3c2-4c6c-bc01-b9b7c97856e2
Set id: 6b0c4ab5-a81e-44b7-87a8-7c5931e28b37
Version: 1
Effective Time: 20200430
 
Ganzhou Olivee Cosmetic Co., Ltd.