HAND SANITIZER- alcohol gel 
Shedrain Corporation

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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Active Ingredient(s)

Ethanol 70%. Purpose: Antimicrobial

Active ingredient

Purpose

Hand sanitizer to help decrease bacteria on the skin.

Purpose

Warnings

Flammable. Keep away from fire or flame.

For external use only

Warning

Do not use

Do not use in or near the eyes. If contact occurs, flush thoroughly with water. Do not use

Stop use and contact doctor if redness and irritation develops and persists.

Stop use

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Keep out of children

Directions

Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

Dosage & Admin

Other information

Store below 110°F (43°C)

Other info

Inactive ingredients

Aqua (Water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Animomethyl Propanol, Aloe Barbadensis Leaf Extract.

Inactive ingredient

Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

Indicate

Package Label - Principal Display Panel

Instant Hand Sanitizer. 50mL

Package label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80380-071
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.6 mL  in 100 mL
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.15 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80380-071-0170 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/23/2020
Labeler - Shedrain Corporation (009025552)
Establishment
NameAddressID/FEIBusiness Operations
XIAMEN ROSEMARY BIOTECHNOLOGY  CO.,LTD543263460manufacture(80380-071)

Revised: 10/2020
Document Id: b2214b3c-3a4d-5dc5-e053-2995a90ab680
Set id: b2214b3c-3a5b-5dc5-e053-2995a90ab680
Version: 1
Effective Time: 20201023
 
Shedrain Corporation