Gentle Hand Soap Antibacterial Rosemary Lavender

Gentle Hand Antibacterial Rosemary Lavender by

Drug Labeling and Warnings

Gentle Hand Antibacterial Rosemary Lavender by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENTLE HAND ANTIBACTERIAL ROSEMARY LAVENDER- benzalkonium chloride soap 
Shalom International 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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Gentle Hand Soap Antibacterial Rosemary Lavender

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

  • For hand washing to decrease bacteria on the skin.

Warnings

  • For external use only

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use & ask a doctor

if irritation or rash appears & lasts.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet hands with water
  • apply palmful to hands and scrub thoroughly 
  • rinse and dry thoroughly
  • intended for repeat use

Inactive Ingredients:

Water (Aqua), Cocamidopropyl Betaine, PEG-150 Distearate, Cocamide MEA, Fragrance (Parfum), Benzyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Benzoic Acid.

Questions?

  • Call 212-391-6970

Package Labeling

Label4

GENTLE HAND ANTIBACTERIAL ROSEMARY LAVENDER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-068-00500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/15/202012/31/2021
Labeler - Shalom International Corp (001384825)

Revised: 3/2022
Document Id: d9d0fb3d-41ac-e44b-e053-2995a90abb44
Set id: b8ed1bb5-2466-4bb9-b121-2fed4b97d7b9
Version: 3
Effective Time: 20220309