BIOMAX USA ANTIBACTERIAL HAND WASH- benzalkonium chloride soap

Biomax USA ANTIBACTERIAL HAND WASH by

Drug Labeling and Warnings

Biomax USA ANTIBACTERIAL HAND WASH by is a Otc medication manufactured, distributed, or labeled by Biomax Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Benzalkonium chloride..........0.13%

Purpose

Antibacterial

Other ingredients:..............99.78%

Aqua/Water/Eau, Cocamidopropyl Betaine, PEG-150-distearate, Cocamide MEA, Aloe Barbadensis Leaf Juice ( Aloe Vera Leaf Juice), Glycerin, Parfum (Fragrance), Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium chloride, Magnesium Nitrate, Citric Acid, CI 19140 (FD&C Yellow No. 5), CI 42090 (FD&C Blue 1).

Uses

hand sanitizer to decrease bacteria on the skin
recommended for repeated use

Warnings

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. FOR USE WITH ADULT SUPERVISION. PRODUCT NOT TESTED ON ANIMALS.

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

Directions

Apply directly on hands, massage and rinse.

SPL UNCLASSIFIED SECTION

HEALTHCARE

aloe vera

Refreshing deep cleanser

NATURALLY CLEAN | SULFATE-FREE | PARABEN-FREE

Wash away harmful bacteria with a light, clean, pleasant scent of Aloe Vera . This moisturizing hand wash with aloe vera oil washes dirt and bacteria for good hand hygiene. 

Fragrance: The reviving scent of Aloe Vera provides an invigorating aromatherapy experience like no other.

Manufactured by:

Biomax Cosmetics Inc.

Houston, TX 77061

www.biomaxcosmetics.com

MADE IN USA

Packaging

INGREDIENTS AND APPEARANCE

BIOMAX USA ANTIBACTERIAL HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77369-955
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77369-955-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020
2	NDC: 77369-955-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/26/2020

Labeler - Biomax Cosmetics (084032031)

Establishment
Name	Address	ID/FEI	Business Operations
Biomax Cosmetics		084032031	manufacture(77369-955)