HYDROCLEAN HAND SANITIZER- benzalkonium chloride 0.13% gel 
Telebrands Corp

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.

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HydroClean Hand Sanitizer

Active ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Benzalkonium Chloride 0.13% w/w...........................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 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

Other information

Store tightly closed in a cool dry place.

Inactive ingredients

Water/Aqua/Eau, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Cocos Nucifera (Coconut) Oil, Cannabis Sativa (Hemp) Seed Oil, Hydroxyethylcellulose, Polysorbate 20, Disodium EDTA, Sodium Citrate, Sodium Hydroxide, Citric Acid, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

Handvana

Odor Free

HydroClean

Hand Sanitizer

Benzalkonium Chloride 0.13%

KILLS 99.9% OF GERMS*

Sanitize + Soften Hands

With Moisturizing

Coconut Oil

Aloe Vera

Hyaluronic Acid

VALUE SIZE

OVER 1lb

17 fl oz (503 mL)

Made in the USA

GEL

HYDROCLEAN HAND SANITIZER 
benzalkonium chloride 0.13% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73287-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73287-007-011 in 1 CARTON04/08/2020
1503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:73287-007-021 in 1 CARTON05/15/2020
23785 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:73287-007-031 in 1 CARTON05/15/2020
3946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4NDC:73287-007-041 in 1 CARTON05/15/2020
459 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:73287-007-051 in 1 CARTON05/15/2020
5236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/08/2020
Labeler - Telebrands Corp (177266558)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm, Inc.146224444manufacture(73287-007)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies Incorporated171837367manufacture(73287-007)

Revised: 5/2020
Document Id: a633db8f-6d4d-3888-e053-2a95a90a8d5d
Set id: a2cb5c58-d5f6-b168-e053-2a95a90ab5f7
Version: 3
Effective Time: 20200521
 
Telebrands Corp