ACP HAND SANITIZER- ethyl alcohol gel 
Swanrose, Inc.

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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ACP Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

Uses

• Hand sanitizer to reduce microorganisms on the skin.
• Use this product when soap and water are not available.

Warnings

• For external use only. • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition. • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours, consult a physician. 

• KEEP OUT OF REACH OF CHILDREN. 

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

Directions

• Read the entire label before using this product.
• Place enough product on your palm to thoroughly cover your hands.
• Rub hands together briskly until dry.

Inactive Ingredients

Water, Glycerine, 1,2 Propylene Glycol, Carbomer, 2-Amino-2-Methyl Propanol

70% Alcohol
Self Drying Gel
Rub well until dry

Distributed & Marketed by Swanrose Inc.
SWANROSE, INC.
751 N. SPAULDING AVENUE
LOS ANGELES, CA 90046
PHONE: +1 (310) 266-5812
Made in China

Packaging

image description

ACP HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78287-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78287-120-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
2NDC:78287-120-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
3NDC:78287-120-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
4NDC:78287-120-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
5NDC:78287-120-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
6NDC:78287-120-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
7NDC:78287-120-07560 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
8NDC:78287-120-08980 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
9NDC:78287-120-092000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
10NDC:78287-120-104000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
11NDC:78287-120-115000 mL in 1 CAN; Type 0: Not a Combination Product06/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/24/2020
Labeler - Swanrose, Inc. (117523391)
Establishment
NameAddressID/FEIBusiness Operations
ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD529558167manufacture(78287-120)

Revised: 6/2020
Document Id: 9903ab1d-9415-4be7-b2c7-206cc8db975b
Set id: bbd1fe34-4a1a-4284-aa6e-6d1cf77ec590
Version: 1
Effective Time: 20200626
 
Swanrose, Inc.