GENTLECARE HAND AND SKIN SANITIZER- benzalkonium chloride liquid

GENTLECARE HAND AND SKIN SANITIZER by

Drug Labeling and Warnings

GENTLECARE HAND AND SKIN SANITIZER by is a Otc medication manufactured, distributed, or labeled by PARAGON SOLUTIONS US, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride, 0.13%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses
■ For sanitizing to reduce bacteria on the skin.

WARNINGS

Warnings
For external use only
When using this product■ Avoid contact with
eyes. ■ In case of eye contact, flush with water.
■ Call doctor if irritation persists.

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.

DOSAGE & ADMINISTRATION

Directions
■ Apply 1 - 2 pump to dry hands, rub into skin.
■ Supervise children in the use of this product.

INACTIVE INGREDIENT

Inactive ingredients
Purified Water, Aloe Vera, Propylene Glycol,
Triethylene Glycol, Polysorbate-20.

Principal Display Panel

GentleCare

Solutions

Foaming

Hand & Skin
Sanitizer

• Kills 99.99% of Germs
• Moisturizes & Conditions
• Alcohol Free, Sting Free
• Fragrance Free

with Aloe Vera
1.7 fl. oz. (50 mL)

Sold by:

GentleCare
Solutions

A division of:
Paragon Solutions US, Inc.
New Hill, NC 27562

www.gentlecare.us

Questions?

Call Us Toll Free

1.800.262.8670
Monday to Friday
9:00 am to 4:00 pm EST

1.7 FL OZ

7.5 FL OZ

16.5 FL OZ

1 GAL

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INGREDIENTS AND APPEARANCE

GENTLECARE HAND AND SKIN SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78181-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78181-020-02	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
2	NDC: 78181-020-07	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
3	NDC: 78181-020-18	550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
4	NDC: 78181-020-28	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2020

Labeler - PARAGON SOLUTIONS US, INC. (069788314)

Registrant - PARAGON SOLUTIONS US, INC. (069788314)

Establishment
Name	Address	ID/FEI	Business Operations
Lifequest Creations LLC		053654857	manufacture(78181-020)