NEUTROGEL- soap gel 
QUIMICA ROSMAR S.A DE C.V

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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77251-008 Neutrogel
Benzethonium chloride 0.10%

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Benzethonium chloride 0.10% w/w. Purpose: Antiseptic

Purpose

Antiseptic

Use

Warnings

For external use only.

Do not use

When using this product do not use

Stop use and ask a doctor if irritation or redness persists for more than 72 hours.

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, sodium lauryl ether sulfate, cocamidopropyl betaine, cocamide DEA, glycerin, propylene glycol, sodium chloride, citric acid, DMDM hydantoin

Package Label - Principal Display Panel

(4000 mL)4000 mL NDC: 77251-008-01

200000 mL NDC: 77251-008-02

20000 mL NDC : 77251-008-03 20000 mL

1000 mL NDC: 77251-008-04 1000 mL

500 mL NDC: 77251-008-05 500 mL

250 mL NDC: 77251-008-06 250 mL200000 mL

NEUTROGEL 
soap gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77251-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77251-008-014000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
2NDC:77251-008-02200000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
3NDC:77251-008-0320000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
4NDC:77251-008-041000 mL in 1 POUCH; Type 0: Not a Combination Product03/30/2020
5NDC:77251-008-05500 mL in 1 POUCH; Type 0: Not a Combination Product03/30/2020
6NDC:77251-008-06250 mL in 1 POUCH; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - QUIMICA ROSMAR S.A DE C.V (814223475)
Establishment
NameAddressID/FEIBusiness Operations
QUIMICA ROSMAR S.A DE C.V814223475manufacture(77251-008)

Revised: 1/2021
Document Id: b8420854-8e2a-42df-e053-2995a90a209e
Set id: b8421201-ea06-388d-e053-2995a90a2ecb
Version: 1
Effective Time: 20210112
 
QUIMICA ROSMAR S.A DE C.V