CC USA BEST GEL HAND SANITIZER- hand sanitizer gel

CC USA Best Gel Hand Sanitizer by

Drug Labeling and Warnings

CC USA Best Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Coil Chem LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 69.62% v/v

Purpose

Antiseptic

Use(s)

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. Flamable. Keep away from heat or flame.

Do not use

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

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 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

• 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.

Other Information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients:

Glycerine, Purified Water, Acrylate Copolymer, Aminomethyl Propanol, Fragrance.

Package Label - Principal Display Panel

3785 mL NDC: 75508-004-03

Package Label - Principal Display Panel

1892.7 mL NDC: 75508-004-10

Package Label - Principal Display Panel

946.35 mL NDC: 75508-004-04

Package Label - Principal Display Panel

473.17 mL NDC: 75508-004-05

Package Label - Principal Display Panel

236.58 mL NDC: 75508-004-06

Package Label - Principal Display Panel

177.44 mL NDC: 75508-004-07

Package Label - Principal Display Panel

118.3 mL NDC: 75508-004-08

Package Label - Principal Display Panel

59 mL NDC: 75508-004-09

Package Label - Principal Display Panel

208198 mL NDC: 75508-004-02

Package Label - Principal Display Panel

999349 mL NDC: 75508-004-01

INGREDIENTS AND APPEARANCE

CC USA BEST GEL HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75508-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69.62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.17 mL  in 100 mL
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)	0.18 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	4.08 mL  in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	0.24 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24.71 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75508-004-01	999349 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/01/2020
2	NDC: 75508-004-02	208198 mL in 1 DRUM; Type 0: Not a Combination Product	05/01/2020
3	NDC: 75508-004-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
4	NDC: 75508-004-04	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
5	NDC: 75508-004-05	473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
6	NDC: 75508-004-06	236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
7	NDC: 75508-004-07	177.44 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
8	NDC: 75508-004-08	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
9	NDC: 75508-004-09	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
10	NDC: 75508-004-10	1892.7 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Coil Chem LLC (963846535)

Establishment
Name	Address	ID/FEI	Business Operations
Coil Chem LLC		963846535	manufacture(75508-004)