57816-008 9054 Hand Sanitizer

9054 Hand Sanitizer by

Drug Labeling and Warnings

9054 Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by LMZ (Jiangsu) Industrial Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

9054 HAND SANITIZER- 9054 hand sanitizer gel 
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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57816-008

9054 Hand Sanitizer

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For Hand Sanitizing

Warnings

For external use only-hands.
Flammable. Keep away from heat and flame.

Do not use

Do not inhale or ingest.

When using this product
Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
Do not inhale or ingest.

Stop use and ask a doctor

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.
For children under 6 age use only under adult supervision.
Not recommended for infants.

Other Information

Do not store above 105°F.
May discolor some fabrics.

Inactive ingredients

Water, Propylene Glycol, Carbomer, Glycerol, Triethanolamine, Fragrance, Tocopheryl acetate

Package Label - Principal Display Panel

57816-008-01 30ml GEL

9054 HAND SANITIZER 
9054 hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57816-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 108 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57816-008-01	30 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(57816-008)

Revised: 12/2022

Document Id: f04eaf2f-4d6b-d285-e053-2a95a90a2ab8

34390-5

Set id: b86ecd00-c4f8-4085-e053-2a95a90afd14

Version: 2

Effective Time: 20221220