PURIDERM ANTIBACTERIAL- benzalkonium chloride liquid

PURIDERM by

Drug Labeling and Warnings

PURIDERM by is a Otc medication manufactured, distributed, or labeled by INDUSTRIAS CHAMER S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium chloride

Purpose

Antibacterial

INDICATIONS & USAGE

Directions

Pump into hands. Massage throughly for at least 20 seconds. Rinse and dry throughly.

Warnings

External use only.

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on irritated skin.

Keep out of reach of children if swallowed, get medical help.

Stop use and ask a doctor if irritation or redness develops and lasts more than 72 hours.

Inactive Ingredients

Aqua (Water), Sodium Laureth Sulfate, Sodium chloride, Cocamidopropyl Betaine, Cocamidopropyl PG Dimonium Chloride, Lauryl Glucoside, Glycerin, Parfum (Fragance), Aloe Barbadensis Extract, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone (and) Methylisothiazolinone, CI 42090, CI 19140, CI 17200.

Questions?

M-F: 8-5 CT

+1 781 519-4494

PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - Spring Fresh

Puriderm™

ANTIBACTERIAL

KILLS 99.9% OF GERMS

LIQUID HAND SOAP

SPRING FRESH
MOISTURIZES AND NOURISHES SKIN

FREE OF GERMS
MAXIMUM PROTECTION

℮ 12 FL OZ (360 mL)

PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - Lavender Vanilla

Puriderm™

ANTIBACTERIAL

KILLS 99.9% OF GERMS

LIQUID HAND SOAP

LAVENDER VANILLA
MOISTURIZES AND NOURISHES SKIN

FREE OF GERMS
MAXIMUM PROTECTION

℮ 12 FL OZ (360 mL)

PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - Fruit Explosion

Puriderm™

ANTIBACTERIAL

KILLS 99.9% OF GERMS

LIQUID HAND SOAP

FRUIT EXPLOSION
MOISTURIZES AND NOURISHES SKIN

FREE OF GERMS
MAXIMUM PROTECTION

℮ 12 FL OZ (360 mL)

INGREDIENTS AND APPEARANCE

PURIDERM   ANTIBACTERIAL
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51774-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)	7.5 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	TURQUOISE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51774-002-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
2	NDC: 51774-002-12	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
3	NDC: 51774-002-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
4	NDC: 51774-002-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/24/2020

PURIDERM   ANTIBACTERIAL
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51774-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)	7.5 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51774-003-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
2	NDC: 51774-003-12	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
3	NDC: 51774-003-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
4	NDC: 51774-003-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/24/2020

PURIDERM   ANTIBACTERIAL
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51774-004
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)	7.5 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51774-004-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
2	NDC: 51774-004-12	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
3	NDC: 51774-004-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
4	NDC: 51774-004-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/24/2020

Labeler - INDUSTRIAS CHAMER S.A. DE C.V. (850602483)

Establishment
Name	Address	ID/FEI	Business Operations
INDUSTRIAS CHAMER S.A. DE C.V.		850602483	MANUFACTURE(51774-002, 51774-003, 51774-004)