TRUE ESSENTIALS HAND SANITIZER- benzalkonium chloride lotion

True Essentials by

Drug Labeling and Warnings

True Essentials by is a Otc medication manufactured, distributed, or labeled by Fortune Hi-Tech, Creations Garden Natural Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:........................Purpose:

Benzalkonium Chloride 0.1%........................Antiseptic

Use:

• To decrease bacteria on the skin that could cause disease.
• Recommended for repeated use.
  

Warnings:

For external use only--skin.

Flammable.

Keep away from heat and flame.

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
  

Stop use and ask a doctor if

skin irritation develops.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Wet skin area thoroughly with product
• Rub hands together until dry
  

Other information

• Do not store above 105°,
• May discolor some fabrics,
• Harmful to wood finishes and plastics.
  

Inactive ingredients

Water, Pentylene Glycol, Dimethicone, Glyceryl Laurate, Distearyldimonium Chloride, Cetyl Alcohol, Glycerin, Tocopheryl (Vitamin E) Acetate, Allantoin, Tetrasodium EDTA, Blue 1, Yellow 5, Fragrance

Questions?

Call 1-859-422-7048

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TRUE ESSENTIALS  HAND SANITIZER
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.59 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL LAURATE (UNII: Y98611C087)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-006-23	59 mL in 1 VIAL, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/13/2011

Labeler - Fortune Hi-Tech (961956229)

Registrant - Creations Garden Natural Products (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products		961956229	manufacture