COOL AND COOL by ABC INTERNATIONAL / ABC INTERNATIONAL LTD / ABC INDUSTRIES LLC Hand sanitizer

Drug Details [pdf]

COOL AND COOL- alcohol hand sanitizer gel
ABC INTERNATIONAL

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

Alcohol 70%, antiseptic

For handwashing to reduce bacteria on the skin.

For external use only.

Water (Aqua), Glycerin

Place enough product on hand and rub hands together until dry.

Antiseptic

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

Label

LABEL FLAMMABLE. DO NOT DRINK OR SWALLOW. STORE IN A COOL DRY PLACE.

COOL AND COOL
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77118-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 um in 60 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	27 um in 60 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 77118-100-60	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/31/2020	05/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/31/2020	05/31/2022

Labeler - ABC INTERNATIONAL (864324525)

Registrant - ABC INTERNATIONAL LTD (864324525)

Name	Address	ID/FEI	Business Operations
Establishment
ABC INDUSTRIES LLC		561180632	manufacture(77118-100)

Revised: 5/2020

Document Id: a5d1358e-95fc-81e8-e053-2995a90aac33

Set id: a5d1358e-95fb-81e8-e053-2995a90aac33

Version: 1

Effective Time: 20200517