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

Neutrogel by

Drug Labeling and Warnings

Neutrogel by is a Otc medication manufactured, distributed, or labeled by QUIMICA ROSMAR S.A DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• For washing sanitizing hands
• Helps reduce bacteria on the skin that potentially can cause disease

Warnings

For external use only.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product do not use

• On children less than 2 months of age
• On open skin wounds

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Wet as needed
• Place enough product in your hand
• Rub gently for at leats 30 seconds
• Wash skin, rinse thoroughly and dry

Other information

• Store at temperature below 110F (43C)

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 NDC: 77251-008-01

200000 mL NDC: 77251-008-02

20000 mL NDC : 77251-008-03

1000 mL NDC: 77251-008-04

500 mL NDC: 77251-008-05

250 mL NDC: 77251-008-06

INGREDIENTS AND APPEARANCE

NEUTROGEL 
soap gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77251-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77251-008-01	4000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77251-008-02	200000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
3	NDC: 77251-008-03	20000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
4	NDC: 77251-008-04	1000 mL in 1 POUCH; Type 0: Not a Combination Product	03/30/2020
5	NDC: 77251-008-05	500 mL in 1 POUCH; Type 0: Not a Combination Product	03/30/2020
6	NDC: 77251-008-06	250 mL in 1 POUCH; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - QUIMICA ROSMAR S.A DE C.V (814223475)

Establishment
Name	Address	ID/FEI	Business Operations
QUIMICA ROSMAR S.A DE C.V		814223475	manufacture(77251-008)