HAND SANITIZER WIPES - alcohol cloth
Genesan Systems

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 Wipes 7830 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

wet hands thoroughly with product and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, propylene glycol

Hand Sanitizer Wipes 7830 70 pre-saturated wipes

783070PG.jpg Hand Sanitizer Wipes 70 pre-saturated wipes image of canister label

HAND SANITIZER WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52030-783
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52030-783-22	295 g in 1 CANISTER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	12/01/2009

Labeler - Genesan Systems (961574576)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture