AQUARELLE by INDELPA, S.A DE C.V

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]

AQUARELLE- benzalkonium chloride swab 
INDELPA, S.A DE C.V

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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Benzalkonium Chloride....0.125%

Antibaterial

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

for external use only

If you are allergic to any of the ingredients

Di not get into eyes. If contact occurs rinse thoroughly with water

If irritation or rash develops and continues for more than 72 hours

If irritation or rash develops and continues for more than 72 hours

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

Throughly wipe hands and face as desired.

Allow to dry without wiping.

Discard wipe in trash receptacle after use. Do not flush

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

Demineralised water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Methylchloroisothiazolinone / Methylisothiazolinone, Fragrance, Aloe Vera Extract, Tretasodium EDTA, Citric Acid, D-alpha Tocopheryl Acetate.

Dossage: swab

Administration: Topical

To dispense wipe: Peel back front label slowly. Remove wipes

To resela Pouch: Firmly run thumb over the label

For external use only

AQUARELLE 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70697-803
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)	98.567 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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.018 mg  in 100 mg
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.1 mg  in 100 mg
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)	0.2 mg  in 100 mg
EDETATE SODIUM (UNII: MP1J8420LU)	0.03 mg  in 100 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70697-803-01	30 in 1 CASE	11/02/2020
1		15 in 1 PACKAGE
1		0.375 mg in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70697-803-02	24 in 1 CASE	11/02/2020
2		0.375 mg in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70697-803-03	12 in 1 CASE	11/02/2020
3		0.375 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	10/01/2020	01/13/2022

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(70697-803) , analysis(70697-803) , pack(70697-803) , label(70697-803)

Revised: 1/2022

Document Id: d57b4799-a2c8-4b47-e053-2a95a90ad649

34390-5

Set id: b3ce3723-3899-d0a3-e053-2a95a90a5305

Version: 2

Effective Time: 20220113