AMBER AND BLACK- benzalkonium chloride soap

Amber and Black by

Drug Labeling and Warnings

Amber and Black by is a Otc medication manufactured, distributed, or labeled by NV Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient Purpose

Benzalkonium Chloride 0.13% v Antibacterial

USES

For handwashing to decrease bacteria of the skin

WARNING

Warnings

For External Use only

When using this product

Avoid Contact with eyes

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation orredness develops.

Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

• Apply to Dry Hands
• Lather vigorously for at least 15 seconds
• Rinse and dry throughly

In active Ingredients

Water (Aqua) , Lauramidopopylamine Oxide, cocamidopropyl Betaine, lauramine Oxide, Sodium Chloride, Glycerin, Myristamine Oxide, Cetrimonium Chloride, Fragrance, PEG-120 Methy Glucose Dioleate, PEG-150 Distearate, Citric Acid, Tetrasodium EDTA, Sodium Benzoate, RED 40, Red 33, Yellow 5.

Manufactured By: Questions or Comments

Manufactured By: Reforma Group, Southfield, Michigan 48033

Questions or comments? Call 1-248-358-9022

Keep out of Reach of Children

Keep out of Reach of Children. If swallowed , get medical help or contact a Poison Control Center right away.

Purpose

Antbacterial

Package Label Principle Display Panel

INGREDIENTS AND APPEARANCE

AMBER AND BLACK 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73696-104
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
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	1.4483 g  in 100 g
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)	0.05 g  in 100 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 g  in 100 g
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)	11 g  in 100 g
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.33 g  in 100 g
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)	0.1 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	1 g  in 100 g
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)	0.1 g  in 100 g
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)	0.3 g  in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	2.15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.5 g  in 100 g
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)	4 g  in 100 g
MYRISTAMINE OXIDE (UNII: J086PM3RRT)	3.8 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	1.2 g  in 100 g
WATER (UNII: 059QF0KO0R)	68.4896 g  in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	9 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73696-104-16	473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/29/2020

Labeler - NV Labs (019662814)

Registrant - NV Labs (019662814)

Establishment
Name	Address	ID/FEI	Business Operations
NV Labs		019662814	manufacture(73696-104)