CC USA NON-ALCOHOL FOAMING HAND SANITIZER- non-alcohol foaming hand sanitizer liquid 
Coil Chem LLC

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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Acctive Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use(s)

For hand washing to help reduce bacteria that cause disease. For use when soap and water are not available.

Inactive Ingredients:

glycerin, decyl glucoside, purified water, aloe vera solution, citric acid.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. No rinsing required.

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

Warnings

For external use only

When using this product

Do not get into eyes. If contact offurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation and redness develop.

Keep out of reach of children.

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

Package Label - Principal Display Panel

999349 mL Tote LabelNDC: 75508-005-01 999349 mL

Package Label - Principal Display Panel

208198 mL Drum LabelNDC: 75508-005-02 208198 mL

Package Label - Principal Display Panel

3785.41 mL Gallon LabelNDC: 75508-005-03 3785.41 mL

Package Label - Principla Display Panel

1892.7 mL half gallon labelNDC: 75508-005-04 1892.7 mL

Package Label - Principal Display Panel

NDC: 75508-005-05 946.35 mL 946.35 mL 32 oz Label

Package Label - Principal Display Panel

473.18 mL 16 oz LabelNDC: 75508-005-06 473.18 mL

Package Label - Principal Display Panel

236.59 mL 8 oz LabelNDC: 75508-005-07 236.59 mL

Package Label - Principal Display Panel

177.4 mL 6 oz LabelNDC: 75508-005-08 177.4 mL

Package Label - Principal Display Panel

118.3 mL 4 oz LabelNDC: 75508-005-09 118.3 mL

Package Label - Principal Display Panel

59.1 mL 2 oz LabelNDC: 75508-005-10 59.1 mL

CC USA NON-ALCOHOL FOAMING HAND SANITIZER 
non-alcohol foaming hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75508-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.005 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 97.355 mL  in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75508-005-01999349 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/01/2020
2NDC:75508-005-02208198 mL in 1 DRUM; Type 0: Not a Combination Product09/01/2020
3NDC:75508-005-033785.41 mL in 1 JUG; Type 0: Not a Combination Product09/01/2020
4NDC:75508-005-041892.7 mL in 1 JUG; Type 0: Not a Combination Product09/01/2020
5NDC:75508-005-05946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
6NDC:75508-005-06473.18 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
7NDC:75508-005-07236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
8NDC:75508-005-08177.4 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
9NDC:75508-005-09118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
10NDC:75508-005-1059.1 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/01/2020
Labeler - Coil Chem LLC (963846535)
Establishment
NameAddressID/FEIBusiness Operations
Coil Chem LLC963846535manufacture(75508-005)

Revised: 9/2020
Document Id: af837ae3-8e6a-740d-e053-2995a90a60e9
Set id: af837ae3-8e69-740d-e053-2995a90a60e9
Version: 1
Effective Time: 20200917
 
Coil Chem LLC