AQUARELLE- benzalkonium chloride cloth

AQUARELLE by

Drug Labeling and Warnings

AQUARELLE by is a Otc medication manufactured, distributed, or labeled by HIGIENE + SALUD, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.125%

PURPOSE

Antibacterial

DO NOT USE

Over large areas of the body if you are allergic to any of the ingredients.

WHEN USING

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 help or contact a Poison Control Center right away.

INDICATIONS & USAGE

· 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. It's antiseptic properties are not affected.

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

DOSAGE & ADMINISTRATION

Dosage: Swab - Administration: Topical

SUMMARY OF SAFETY AND EFFECTIVENESS

• Convenient

Easy to use & carry anywhere!

• Clean-up

Use to wash up quickly when soap and water are not available.

• Moisturize

Contains soothing Aloe to help moisturize your skin and leave it feeling soft and smooth.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AQUARELLE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52629-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.125 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	98.54 mg  in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 mg  in 100 mg
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.3 mg  in 100 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.01 mg  in 100 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mg  in 100 mg
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)	0.2 mg  in 100 mg
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	0.1 mg  in 100 mg
EDETATE SODIUM (UNII: MP1J8420LU)	0.03 mg  in 100 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.018 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52629-801-03	16 in 1 BOX	07/01/2020
1		1 in 1 PACKAGE
1		0.3 mg 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	07/01/2020

Labeler - HIGIENE + SALUD, S.A. DE C.V. (814608832)

Registrant - HIGIENE + SALUD, S.A. DE C.V. (814608832)

Establishment
Name	Address	ID/FEI	Business Operations
HIGIENE + SALUD, S.A. DE C.V.		814608832	manufacture(52629-801) , pack(52629-801) , label(52629-801)