PROCURE HAND SANITIZING- alcohol swab

ProCure Hand Sanitizing by

Drug Labeling and Warnings

ProCure Hand Sanitizing by is a Otc medication manufactured, distributed, or labeled by TwinMed, LLC, American Hygienics Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 65.9% BY VOLUME

PURPOSE

Antiseptic

Uses

- Antiseptic

- For handwashing to decrease bacteria on the skin; after assisting ill persons; and before contact with a person under medical care treatment

- Apply topically to the skin to hep prevent cross-contamination

- Recommended for repeated use.

- Dries in seconds

WARNINGS

Flammable, keep away from fire and flame

For extermal use only.

Do not use

in or contact the eyes

Discontinue use

If irritation and redness develop. If condition persists for more than 72 hours, consult a physician.

Keep this out of reach of children

unless under adult supervision.

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

Directions

To start feed: REmove cover and discard seal from container. From center of toweled roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through hole in the container cover. Pull thrugh about one inch. Replace cover. Pull out wipes as needed and sanp off at a 90 degree angle. Keep cap closed to prevent evaporation.

Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry.

If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe.

Discard after single use.

Other Information

Lot Number and Expiration Date can be found on container

Inactive Ingredients

Water, Propylene glycol, Glycerin, Carbomer, Aminomethylpropanol, Aloe barbadensis leaf juice, Tocopheryl acetate.

Labeling

INGREDIENTS AND APPEARANCE

PROCURE HAND SANITIZING 
alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57544-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57544-180-16	320 g in 1 CANISTER; Type 0: Not a Combination Product	05/07/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/07/2013

Labeler - TwinMed, LLC (009579330)

Registrant - TwinMed, LLC (009579330)

Establishment
Name	Address	ID/FEI	Business Operations
TwinMed, LLC		009579330	relabel(57544-180)

Establishment
Name	Address	ID/FEI	Business Operations
American Hygienics Corporation		545198454	manufacture(57544-180)