AccuMed Antibacterial Hand Sanitizing Wipes by ACCUMED BIOTECH LLC / AMERICAN HYGIENICS CORPORATION

AccuMed Antibacterial Hand Sanitizing Wipes by

Drug Labeling and Warnings

AccuMed Antibacterial Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by ACCUMED BIOTECH LLC, AMERICAN HYGIENICS CORPORATION . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACCUMED ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth 
ACCUMED BIOTECH 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.

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Directions

■ Open resealable label, remove one wipe to use ■ Wipe hand thoroughly with product and allow to dry without wiping. ■ Close resealable label after use to retain moisture.

Antibacterial

■ For handwashing to decrease bacteria on the skin.

Benzalkonium chloride 0.11%

Inactive ingredient 2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

■ Do not use on eyes. If eye contact occurs, rinse eyes thoroughly with water. ■ Do not flush.■ Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

ACCUMED ANTIBACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81204-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
3-HEXYLOXYPROPYLENE GLYCOL (UNII: 3485P35DA4)
BRONOPOL (UNII: 6PU1E16C9W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81204-001-01	30 in 1 POUCH	07/15/2021
1		2.9 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2021

Labeler - ACCUMED BIOTECH LLC (079860728)

Establishment
Name	Address	ID/FEI	Business Operations
AHC Ltd		413138557	manufacture(81204-001)

Revised: 7/2023

Document Id: 0038f516-ca67-3338-e063-6394a90a250c

34390-5

Set id: c62b66b2-8a59-3a28-e053-2a95a90aa06b

Version: 2

Effective Time: 20230711