AQUARELLE- benzalkonium chloride liquid

AQUARELLE by

Drug Labeling and Warnings

AQUARELLE 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 0.12%

PURPOSE

Purpose: Antibacterial

INDICATIONS & USAGE

helps eliminate bacteria on hands

WARNINGS

For external use only.

WHEN USING

avoid contact with eyes.
In case of contact, flush with water.

KEEP OUT OF REACH OF CHILDREN

Except under adult supervision.

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

INSTRUCTIONS FOR USE

wash hands and rise.

DOSAGE & ADMINISTRATION

Liquid.... Topical

INACTIVE INGREDIENT

Water, Sodium Lauryl Sulfate, Cocobetaine, Sodium Chloride, Glycerin USP,
Fragrance, Polysorbate 20, Methylchloroisotiazolinone/ Methylisotiazolinone, Citric
Acid, Color FD&C Blue # 1, Color FD&C Red # 33.

PRINCIPAL DISPLAY PANEL

Hand Soap Antibacterial Fresh Scent

Hand Soap 250 ml- Dispensing

7.6 fl. oz (250 mL)

INGREDIENTS AND APPEARANCE

AQUARELLE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70697-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)	8.5 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2.5 mg  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	3 mg  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.0087 mg  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.3 mg  in 100 mL
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.1 mg  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	3 mg  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.000008 mg  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.000035 mg  in 100 mL
WATER (UNII: 059QF0KO0R)	82.121 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70697-804-01	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/10/2020

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	analysis(70697-804) , manufacture(70697-804) , label(70697-804) , pack(70697-804)