DERMACEN INSTANT HAND SANITIZER - alcohol liquid 
Central Solutions 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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Drug Facts

Active Ingredients

Ethanol 64.5% (w/w)

Purpose

Hand Sanitizer

Uses

An antiseptic hand sanitizer for topical application

Prevents infection and cross contamination

Reduces transient microorganisms on intact skin

Keep hands from drying due to repeated uses

Warnings

For External Use Only

Flammable, keep away from fire or flame

When using this product

Avoid contact with eyes

In case of eye contact, flush with water for 15 minutes

Discontinue use and see a doctor if irritation occurs

Avoid contact with broken skin

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product.

Allow to dry without wiping.

Use no water or towels.

Other Information

This product has not been tested on animals.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, Water

DermaCen

Instant

Hand Sanitizer

For hand washing to decrease bacteria on the skin.

Net Contents 8 ounces (236 ml)

container label

DERMACEN INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol64.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETIC ACID (UNII: 9G34HU7RV0)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62654-140-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
2NDC:62654-140-03443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
3NDC:62654-140-36800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
4NDC:62654-140-901000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
5NDC:62654-140-921250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
6NDC:62654-140-911000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2018
7NDC:62654-140-932000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2001
Labeler - Central Solutions Inc (007118524)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions Inc007118524manufacture(62654-140)

Revised: 12/2018
Document Id: aa1f8315-5fc6-4a77-b2f4-ac1426d73a1a
Set id: 36783d30-a222-40fe-a5ea-61a2842a34c9
Version: 2
Effective Time: 20181205
 
Central Solutions Inc