Handvana™ HYDROCLEAN HAND SANITIZER

Handvana HydroClean Hand Sanitizer by

Drug Labeling and Warnings

Handvana HydroClean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cemi International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HANDVANA HYDROCLEAN HAND SANITIZER- benzalkonium chloride gel 
Cemi International, Inc

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.

----------

Handvana™ HYDROCLEAN HAND SANITIZER

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic

Uses

Antiseptic cleansing of hands and body to decrease bacteria on skin without soap and water.

Warnings

For external use only

Do not use

■ in children less than 2 months of age

■ on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

■ irritation or rash occurs. These might be signs of a serious condition.

■ condition persists for more than 72 hours

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

Directions

■ Apply a small amount of gel into palm of hand. Rub thoroughly over all surfaces of both hands for 15 seconds. Allow hands to dry without wiping.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information Store tightly closed in a cool dry place.

Inactive Ingredients Water, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Cannabis Sativa Seed Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Tocopheryl Acetate, Propylene Glycol, Polyquaternium-7, Polysorbate 20, Aminomethyl Propanol, Phenoxyethanol, Blue 1, Yellow 5

Questions? Call (800) 715-0695 (M-F, 9am-5pm EST)

Odor Free

KILLS 99.9% OF GERMS*

​Sanitize + Soften Hands

With Moisturizing

• Coconut Oil
• Aloe Vera
• Hyaluronic Acid

VALUE SIZE

 OVER 1lb

FORMULATED IN THE USA

*Kills 99.9% of Common Germs

©2020 Health Bloom

Distributed by:
Telebrands Corp.
79 Two Bridges Road,
Fairfield, NJ 07004

Packaging

HANDVANA HYDROCLEAN HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73741-101
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 LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 73741-101-17	503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/24/2020	10/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/24/2020	10/18/2023

Labeler - Cemi International, Inc (015038336)

Establishment
Name	Address	ID/FEI	Business Operations
Cemi International, Inc		015038336	manufacture(73741-101) , pack(73741-101)

Revised: 6/2023

Document Id: bb85401c-2d8d-4771-87bd-5c0d970b7dbc

34390-5

Set id: aa7dc169-c5c1-49d4-a5ed-794389cf7544

Version: 2

Effective Time: 20230621