ANTIMICROBIAL HAND SANITIZER GEL - FRESH- alcohol rub gel

Antimicrobial Hand Sanitizer Gel - Fresh by

Drug Labeling and Warnings

Antimicrobial Hand Sanitizer Gel - Fresh by is a Otc medication manufactured, distributed, or labeled by Hanover Pen Corp dba HPC Global, Robert Houghland, Safetec of America Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on skin.
• Recommended for repeated use.

Warnings

for external use only.

Flammable, keep away from fire or flame.

Do not use in the eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor if iritation and redness develop and persists for more than 72 hours.

Keep out of reach of children.

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

Directions

• wet hands thoroughly with product allow to dry without wiping.
• children under six should be supervised while using this product.

Inactive Ingredients

aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Pkgd by HPC Global, Hanover PA, 17331

Made in USA 0.50 fl. oz. Lot# ****

PRINCIPAL DISPLAY PANEL

Drug Facts

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL HAND SANITIZER GEL - FRESH 
alcohol rub gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51811-716
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	10.353 mL  in 14.79 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51811-716-10	14.79 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/13/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/13/2010

Labeler - Hanover Pen Corp dba HPC Global (003022670)

Registrant - Robert Houghland (003022670)

Establishment
Name	Address	ID/FEI	Business Operations
Hanover Pen Corp dba HPC Global		003022670	relabel(51811-716) , repack(51811-716)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America Inc		874965262	manufacture(51811-716)