ProCure Hand Sanitizing: Package Insert and Label Information

PROCURE HAND SANITIZING- alcohol swab
TwinMed, LLC

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.

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

label
(click image for full-size original)

PROCURE HAND SANITIZING
alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57544-180
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 65.9 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
GLYCERIN
AMINOMETHYLPROPANOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57544-180-16 320 g in 1 CANISTER None
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 (107071289)
Registrant — TwinMed, LLC (107071289)
Establishment
Name Address ID/FEI Operations
TwinMed, LLC 107071289 relabel (57544-180)
Establishment
Name Address ID/FEI Operations
American Hygienics Corporation 545198454 manufacture (57544-180)

Revised: 11/2020 TwinMed, LLC

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