HAND SANITIZER- alcohol gel 
Davemed Healthcare 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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Hand Sanitizer Davemed Healthcare Co., Ltd

Active Ingredient

Ethyl Alcohol 70% v/v

USES

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

WARNING:

Flammable.

Keep away from fire or flame.

For external use of onlyh.

WHEN USING THIS PRODUCT:

avoid contact with eyes in case of eye contact immediately flush eyes with water, call a doctor avoid contact with broken skin.

STOP USE AND ASK A DOCTOR:

Discontinue use if irritation or redness develos, If condition persists from more than 72 hours, consult a doctor

KEEP OUT OF CHILDREN:

Children should only use this product under adult supervision

DIRECTIONS:

INGREDIENTS:

Water, Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-40, Hydrogenated Castor Oil, Parfum, Triethanolamine

Antiseptic

Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-012
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)  
WATER (UNII: 059QF0KO0R)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70897-012-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
2NDC:70897-012-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
3NDC:70897-012-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
4NDC:70897-012-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
5NDC:70897-012-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
6NDC:70897-012-06200 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
7NDC:70897-012-07250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
8NDC:70897-012-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
9NDC:70897-012-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
10NDC:70897-012-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
11NDC:70897-012-115000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
12NDC:70897-012-123780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/30/2020
Labeler - Davemed Healthcare Co., Ltd (529128716)
Establishment
NameAddressID/FEIBusiness Operations
Davemed Healthcare Co., Ltd529128716manufacture(70897-012)

Revised: 7/2020
Document Id: abad24b7-d816-e6bb-e053-2995a90a9189
Set id: abad24b7-d815-e6bb-e053-2995a90a9189
Version: 1
Effective Time: 20200730
 
Davemed Healthcare Co., Ltd