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, Alternifolia (Tea Tree Leaf Oil), Glycerin, Menthol, Menthyl Lactate, Parfum (Fragrance), Tetrasodium EDTA, Mica, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium chloride, Magnesium Nitrate, Citric Acid, 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

Refreshing deep cleanser

NATURALLY CLEAN | SULFATE-FREE | PARABEN-FREE

Wash away dirt and grime with Tea Tree Hand Soap. This refreshing hand wash with tea tree oil deep cleans hands and invigorates the senses with the reviving scent of tea tree and peppermint. 

Fragrance: The reviving scent of tea tree provides an invigorating aromatherapy experience like no other.

Ingredient Spotlight: Contains the famous Tingle Complex-a blend of tea tree and peppermint that leaves a cooling, "tingling" sensation. Tea tree oil is a natural antiseptic and germicide with healing properties.

Manufactured by:

Biomax Cosmetics Inc.

Houston, TX

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: 77369-905
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)
TEA LEAF OIL (UNII: VC855RRT77)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
EDETATE SODIUM (UNII: MP1J8420LU)
MICA (UNII: V8A1AW0880)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77369-905-16	473 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	part333E	07/26/2020

Labeler - Biomax Cosmetics (084032031)

Establishment
Name	Address	ID/FEI	Business Operations
Biomax Cosmetics		084032031	manufacture(77369-905)