ANTIBACTERIAL WET WIPES- benzalkonium choride liquid

Antibacterial Wet Wipes by

Drug Labeling and Warnings

Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by INDELPA, S.A DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.130%

PURPOSE

Antibacterial

INDICATIONS & USAGE

For hand washing to decrease bacteria on
the skin. May be used on face, arms and
legs.

WARNINGS

For external use only

DO NOT USE

if you are allergic to any of the ingredients

WHEN USING

this product do not get into eyes. If contact occurs, rinse thoroughly with water.

STOP USE

if irritation or rash develops and continues for more than 72 hours.

ASK DOCTOR

if irritation or rash develops and continues for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

• Thoroughly wipe hands and face as

desired.

• Allow to dry without wiping.
• Discard wipe in trash receptacle after
  use. Do not flush.

STORAGE AND HANDLING

Store at room temperature. Cold weather
may cloud this product. Its antisceptic
properties are not affected.

INACTIVE INGREDIENT

Water, Propylene Glycol, Polysorbate 20,
Sodium Cocoamphoacetate,Fragrance,
Methylchloroisothiazolinone, Aloe Extract,
Tetrasodium EDTA, Citric Acid, Vitamin E.

DOSAGE & ADMINISTRATION

Dosage: Liquid

Administration: Topical

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WET WIPES 
benzalkonium choride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70697-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.3 g  in 100 g
EDETATE SODIUM (UNII: MP1J8420LU)	0.03 g  in 100 g
WATER (UNII: 059QF0KO0R)	98.562 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.018 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 g  in 100 g
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.1 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.01 g  in 100 g
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	0.1 g  in 100 g
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)	0.2 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70697-801-04	24 in 1 CASE	03/25/2020
1		113.2 g 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	part333E	03/25/2020

Labeler - INDELPA, S.A DE C.V (811072487)

Registrant - INDELPA, S.A DE C.V (811072487)

Establishment
Name	Address	ID/FEI	Business Operations
INDELPA, S.A DE C.V		811072487	manufacture(70697-801) , analysis(70697-801) , pack(70697-801) , label(70697-801)