AMBER AND BLACK- benzalkonium chloride soap 
NV Labs

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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Amber and Black Antibacterial Hand Soap (16 Fl. Oz .)

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

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

Anti bacterial Soap

AMBER AND BLACK 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73696-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) 0.3 g  in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA) 2.15 g  in 100 g
MYRISTAMINE OXIDE (UNII: J086PM3RRT) 3.8 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) 4 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
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.1 g  in 100 g
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73696-104-16473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
Labeler - NV Labs (019662814)
Registrant - NV Labs (019662814)
Establishment
NameAddressID/FEIBusiness Operations
NV Labs019662814manufacture(73696-104)

Revised: 1/2022
Document Id: d5788ee8-49fb-1bcb-e053-2a95a90a7f84
Set id: a470baf8-dbb6-a7a2-e053-2a95a90a97ea
Version: 2
Effective Time: 20220113
 
NV Labs