Social Grace Alcohol Free Hand Sanitizer Eucalyptus Lavender by LAB-CLEAN, INC

Social Grace Alcohol Free Hand Sanitizer Eucalyptus Lavender by

Drug Labeling and Warnings

Social Grace Alcohol Free Hand Sanitizer Eucalyptus Lavender by is a Otc medication manufactured, distributed, or labeled by LAB-CLEAN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOCIAL GRACE ALCOHOL FREE HAND SANITIZER EUCALYPTUS LAVENDER- 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

Uses

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. Do not ingest.

Stop use and ask a doctor if irritation or redness develops and conditions persist.

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

SOCIAL GRACE ALCOHOL FREE HAND SANITIZER EUCALYPTUS LAVENDER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73126-019
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73126-019-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 73126-019-02	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 73126-019-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC: 73126-019-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
5	NDC: 73126-019-05	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
6	NDC: 73126-019-06	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020	04/20/2024

Labeler - LAB-CLEAN, INC (199822219)

Establishment
Name	Address	ID/FEI	Business Operations
LAB-CLEAN, INC		199822219	manufacture(73126-019)

Revised: 4/2022

Document Id: dd94162d-9c49-9b9a-e053-2995a90af841

34390-5

Set id: 2480603d-ff8c-417f-bae7-f4b5fe398be1

Version: 3

Effective Time: 20220426