57816-010 Sipa Foaming Hand Sanitizer Alcohol Free

Sipa Foaming Hand Sanitizer Alcohol Free by

Drug Labeling and Warnings

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

Drug Details [pdf]

SIPA FOAMING HAND SANITIZER ALCOHOL FREE- instant hand sanitizer liquid 
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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57816-010

Sipa Foaming Hand Sanitizer Alcohol Free

Active ingredient

Benzalkonium chloride 0.15%

Purpose

Uses

For hand sanitizing to decrease bacteria on the skin

Warnings

For external use only

Do not use

Do not use in Or near the eyes
in case of contact,rinse eyes thoroughly with water

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 and lasts

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

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children

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

Other Information

Pump d small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry

Inactive ingredients

Water, Didecyldimonium Chloride, Glycerin, Propylene Glycol, Peg-10 Dimethicone, Peg-17 Dimethicone, Phenoxyethanol

Package Label - Principal Display Panel

50ml 57816-010-01

50ml 57816-010-01

60ml 57816-010-02

60ml 57816-010-02100ml 57816-010-03

100ml 57816-010-03

236ml 57816-010-04

236ml 57816-010-04

250ml 57816-010-05

250ml 57816-010-05320ml 57816-010-06

320ml 57816-010-06

473ml 57816-010-07

473ml 57816-010-07

502ml 57816-010-08

502ml 57816-010-08946ml 57816-010-09

946ml 57816-010-09

3780ml 57816-010-10

3780ml 57816-010-10

SIPA FOAMING HAND SANITIZER ALCOHOL FREE 
instant hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 57816-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PEG/PPG-17/18 DIMETHICONE (UNII: 2E4ZJH3Z6R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 57816-010-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
2NDC: 57816-010-07473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
3NDC: 57816-010-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
4NDC: 57816-010-08502 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
5NDC: 57816-010-09946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
6NDC: 57816-010-103780 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
7NDC: 57816-010-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
8NDC: 57816-010-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
9NDC: 57816-010-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
10NDC: 57816-010-06320 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/29/202012/21/2022
Labeler - LMZ (Jiangsu) Industrial Co.,Ltd (546645164)
Registrant - LMZ (Jiangsu) Industrial Co.,Ltd (546645164)
Establishment
NameAddressID/FEIBusiness Operations
LMZ (Jiangsu) Industrial Co.,Ltd546645164manufacture(57816-010)

Revised: 12/2022
Document Id: f04ebd0f-56d5-df15-e053-2995a90a605a
Set id: b9016a0d-e336-c8bb-e053-2a95a90a9dad
Version: 2
Effective Time: 20221220