57816-011 90018 Sanitizer Pen

90018 Sanitizer Pen by

Drug Labeling and Warnings

90018 Sanitizer Pen by is a Otc medication manufactured, distributed, or labeled by LMZ (Jiangsu) Industrial Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

90018 SANITIZER PEN- 90018 sanitizer pen spray 
LMZ (Jiangsu) Industrial Co.,Ltd

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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57816-011

90018 Sanitizer Pen

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For Hand Sanitizing

Warnings

For external use only-hands.
Flammable. Keep away from heat and flame.
Keep out of reach of children.

Do not use

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 contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs.
These may be signs of a serious condition.

Keep out of reach of children

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

Directions

in children less than 2 months of age on open skin wounds.

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

[STORAGE AND HANDLING SECTION]EDIT Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerol, Fragrance

Package Label - Principal Display Panel

57816-011-01 5ml SPRAY

90018 SANITIZER PEN 
90018 sanitizer pen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57816-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 110 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57816-011-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/29/2020	12/21/2022

Labeler - LMZ (Jiangsu) Industrial Co.,Ltd (546645164)

Registrant - LMZ (Jiangsu) Industrial Co.,Ltd (546645164)

Establishment
Name	Address	ID/FEI	Business Operations
LMZ (Jiangsu) Industrial Co.,Ltd		546645164	manufacture(57816-011)

Revised: 12/2022

Document Id: f04ec2ea-ded8-446e-e053-2995a90a86a5

34390-5

Set id: bf4a5e48-b120-f1e1-e053-2995a90aa552

Version: 2

Effective Time: 20221220