Sume Apothecary Alcohol Free Hand Sanitizer Lavender and White Sage by LAB-CLEAN, INC

Sume Apothecary Alcohol Free Hand Sanitizer Lavender and White Sage by

Drug Labeling and Warnings

Sume Apothecary Alcohol Free Hand Sanitizer Lavender and White Sage by is a Otc medication manufactured, distributed, or labeled by LAB-CLEAN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUME APOTHECARY ALCOHOL FREE HAND SANITIZER LAVENDER AND WHITE SAGE- benzalkonium chloride liquid 
LAB-CLEAN, 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.

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Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only!

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if 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

Spray a small amount of product into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Package Label - Principal Display Panel

Label

SUME APOTHECARY ALCOHOL FREE HAND SANITIZER LAVENDER AND WHITE SAGE 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73126-013
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)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73126-013-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/2020
2NDC: 73126-013-02355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/09/202004/20/2024
Labeler - LAB-CLEAN, INC (199822219)
Establishment
NameAddressID/FEIBusiness Operations
LAB-CLEAN, INC199822219manufacture(73126-013)

Revised: 4/2022
 

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