HAND SANITIZER- alcohol solution

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Big Bang Services, L.L.C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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).

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (73%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.5% w/w).

3. Hydroxypropylcellulose(Kulcel H) (1.1% w/w).

4. Ceraphyl 31 ester (1.0% w/w)

a. Lauryl Alcohol

b. Myristyl Alcohol

c. Cetyl Alcohol
5. Denatonium benzoate
6. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 73% w/w. 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. Flammable. Keep away from heat or flame

Do not use

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

WHEN USING

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

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

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

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

purified water USP, hydroxypropyl cellulose, glycerin, myristyl lactate,
cetyl lactate, lauryl lactate, denatonium benzoate(bitterant/denaturant)

PRINCIPAL DISPLAY PANEL

5 ml NDC: 75184-003-01

59 ml NDC: 75184-003-02

118 ml NDC: 75184-003-04

237 ml NDC: 75184-003-08

3785 ml NDC: 75184-003-10

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75184-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2391 mL  in 3785 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL LACTATE (UNII: A7EVH2RK4O)	0.01 mL  in 3785 mL
MYRISTYL LACTATE (UNII: 1D822OC34X)	0.05 mL  in 3785 mL
GLYCERIN (UNII: PDC6A3C0OX)	70 mL  in 3785 mL
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)	36 mL  in 3785 mL
LAURYL LACTATE (UNII: G5SU0BFK7O)	0.08 mL  in 3785 mL
WATER (UNII: 059QF0KO0R)	754 mL  in 3785 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.02 mL  in 3785 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75184-003-01	5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/11/2020
2	NDC: 75184-003-02	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/11/2020
3	NDC: 75184-003-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/11/2020
4	NDC: 75184-003-10	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
5	NDC: 75184-003-04	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/11/2020

Labeler - Big Bang Services, L.L.C (062278201)

Registrant - Big Bang Services, L.L.C (062278201)

Establishment
Name	Address	ID/FEI	Business Operations
Big Bang Services, L.L.C		062278201	manufacture(75184-003)