HAND SANITIZER- alcohol gel 
HAND SANITIZER- alcohol spray 
Camden Passage Inc.

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.

----------

Ocean Free - Hand Sanitizer

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)

Alcohol 80% v/v. 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

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 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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

70jug.jpg is the 5L 70% alcohol-based sanitizer NDC: 77385-033-76

NDC 77385-033-76

70pump.jpg is the 500mL 70% alcohol-based sanitizer NDC: 77385-034-13

NDC: 77385-034-13

80jug.jpg is the 5L 80% alcohol-based sanitizer NDC: 77385-057-38

NDC: 77385-057-38

80pump.jpg is the 500 mL 80% alcohol-based sanitizer NDC: 77385-057-52

NDC: 77385-057-52

5L Antiseptic Disinfectant_v01.jpg is the 5L 70% alcohol-based sanitizer NDC 77385-028-05

NDC 77385-028-05

500mL Antiseptic Disinfectant_v01.jpg is the 500mL 70% alcohol-based sanitizer spray NDC 77385-028-29

NDC 77385-028-29

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77385-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.33 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.4 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 20 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL  in 100 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77385-034-13800 in 1 CASE12/07/2018
120 in 1 CARTON
1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/07/2018
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77385-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.33 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.4 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 20 mL  in 100 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.6 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77385-033-76160 in 1 CASE12/07/2018
14 in 1 CARTON
15000 mL in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/07/2018
HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77385-057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.014 L  in 1 L
WATER (UNII: 059QF0KO0R) 0.2 L  in 1 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 L  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77385-057-38160 in 1 CASE12/07/2018
14 in 1 CARTON
15 L in 1 JUG; Type 0: Not a Combination Product
2NDC:77385-057-52800 in 1 CASE12/07/2018
220 in 1 CARTON
20.5 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/07/2018
HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77385-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77385-028-29800 in 1 PACKAGE12/07/2018
120 in 1 CARTON
1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:77385-028-05160 in 1 PACKAGE12/07/2018
24 in 1 CARTON
25000 mL in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34412/07/2018
Labeler - Camden Passage Inc. (250929382)
Registrant - Rook Quality Systems (929885247)
Establishment
NameAddressID/FEIBusiness Operations
Camden Passage Inc.250929382manufacture(77385-057, 77385-033, 77385-034, 77385-028)

Revised: 5/2020
Document Id: a5b3455a-e847-7d4b-e053-2995a90adee3
Set id: a55fae03-213c-61df-e053-2995a90a5a47
Version: 2
Effective Time: 20200515
 
Camden Passage Inc.