HAND SANITIZER- benzalkonium chloride gel 
NATURATLALI S DE RL DE CV

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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77143-002
Benzalkonium Chloride, Alcohol Free

Active Ingredient(s)

Benzalkonium Chloride 0.13% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

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

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

water, hydroxyethylcellulose, glycerin, methylparaben, propylparaben, propylene glycol, DMDM Hydantoin, FD&C Blue No 1

Package Label - Principal Display Panel

500 mL NDC: 77143-002-02

Nat 500mL

250 mL NDC: 77143-002-03

Nat 250mL

5000 mL NDC: 77143-002-04 5 L

1000 mL NDC: 77143-002-05 Alpha 1L

1000 mL NDC: 77143-002-06 CP 1L

500 mL NDC: 77143-002-07 CP 500mL

500 mL NDC: 77143-002-08 Alpha 500ml

250 mL NDC: 77143-003-09 Alpha 250

5000 mL NDC: 77143-002-10 alpha 5L

3785 mL NDC: 77143-002-11 CP gal

5000 mL NDC: 77143-002-12 Q5L

250 mL NDC: 77143-002-13 quarter 250

500 mL NDC: 77143-002-14 quarter 500

1000 mL NDC: 77143-002-15 1Lquarter

3785 mL NDC: 77143-002-16 gal quarter

3785 mL NDC: 77143-002-17

Nat 3785mL

100 mL NDC: 77143-002-22

PDP 100 ml Quater

HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77143-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.25 mL  in 100 mL
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 0.1 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T) 0.025 g  in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.025 g  in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.025 g  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.005 g  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.025 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77143-002-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
2NDC:77143-002-105000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/202011/23/2020
3NDC:77143-002-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
4NDC:77143-002-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:77143-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:77143-002-045000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
7NDC:77143-002-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
8NDC:77143-002-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
9NDC:77143-002-09250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
10NDC:77143-002-113785 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/202011/23/2020
11NDC:77143-002-125000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
12NDC:77143-002-13250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
13NDC:77143-002-14500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
14NDC:77143-002-151000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
15NDC:77143-002-163785 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/202011/23/2020
16NDC:77143-002-173785 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
17NDC:77143-002-22100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - NATURATLALI S DE RL DE CV (951577202)
Registrant - NATURATLALI S DE RL DE CV (951577202)
Establishment
NameAddressID/FEIBusiness Operations
NATURATLALI S DE RL DE CV951577202manufacture(77143-002) , pack(77143-002) , label(77143-002)

Revised: 2/2021
Document Id: bc0b706a-f032-f75b-e053-2a95a90a1086
Set id: a6bd09d4-ebea-0f2d-e053-2a95a90a5f30
Version: 5
Effective Time: 20210223
 
NATURATLALI S DE RL DE CV