57816-001 Instant hand sanitizer

not have by

Drug Labeling and Warnings

not have by is a Otc medication manufactured, distributed, or labeled by LMZ (Jiangsu) Industrial Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NOT HAVE- instant 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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57816-001

Instant hand sanitizer

Active ingredient

Ethyl Alcohol 75%

Purpose

Antimicrobial

Uses

To remove bacteria and germs from the skin

Warnings

For external use only

Flammable-keep away from fire or open flames

Do not use

In or near the eyes in case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor

If irritation or rash appears

Keep out of reach of children

If swallowed seek medical help or contact your local GP as soon as possible

Directions

Squeeze small amount in your palm and rub hands together briskly until dry

Other Information

Do not store above 110°F(43℃)

May discolor some fabrics or surfaces

Inactive ingredients

Carbomer, Triethanolamine, Glycerin,Water

Package Label - Principal Display Panel

57816-001-15 236ml30 ml label 40 ml label 50 ml label 60 ml label 100 ml label 125 ml label 240 ml label 250 ml label 300 ml label 400 ml label 500 ml label 1000 ml label 3800 ml label 5000 ml label

NOT HAVE 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 57816-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 57816-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC: 57816-001-0240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
3NDC: 57816-001-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
4NDC: 57816-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
5NDC: 57816-001-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
6NDC: 57816-001-06125 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
7NDC: 57816-001-07240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
8NDC: 57816-001-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
9NDC: 57816-001-09300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
10NDC: 57816-001-10400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
11NDC: 57816-001-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
12NDC: 57816-001-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
13NDC: 57816-001-133800 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
14NDC: 57816-001-145000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
15NDC: 57816-001-15236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/202012/21/2022
Labeler - LMZ (Jiangsu) Industrial Co.,Ltd (546645164)
Registrant - LMZ (Jiangsu) Industrial Co.,Ltd (546645164)
Establishment
NameAddressID/FEIBusiness Operations
LMZ (Jiangsu) Industrial Co.,Ltd546645164manufacture(57816-001)

Revised: 12/2022
Document Id: f04e82d5-c7f6-446a-e053-2995a90aa6ee
Set id: a78e5b3b-7431-0eab-e053-2a95a90a1cd1
Version: 6
Effective Time: 20221220