OSDS Hand Sanitizer by SCR Cosmetic Corporation

OSDS Hand Sanitizer by

Drug Labeling and Warnings

OSDS Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SCR Cosmetic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OSDS HAND SANITIZER- alcohol gel 
SCR Cosmetic Corporation

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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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) (70%, 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 (1.00% v/v).
  3. 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 70% 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

  • in 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 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

  • 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

glycerin, purified water USP

Package Label - Principal Display Panel

300 mL NDC: 78486-220-01

Hand Sanitizer 300 mL

Hand Sanitizer 300mL Label Design 2Hand Sanitizer 300 mL Label Design 3Hand Sanitizer 300 mL Label Design 4

3800 mL NDC: 78486-220-02

OSDS Hand Sanitizer 3800mL

OSDS Hand Sanitizer 3800mLOSDS Hand Sanitizer 3800mL

OSDS Hand Sanitizer 3800mL

500 mL NDC: 78486-220-03

OSDS Hand Sanitizer 500mLOSDS Hand Sanitizer 500mL (2)OSDS Hand Sanitizer 500mL (3)OSDS Hand Sanitizer 500mL (4)

110 mL NDC: 78486-220-04

OSDS Hand Sanitizer 110mLOSDS Hand Sanitizer 110mL (2)OSDS Hand Sanitizer 110mL (3)OSDS Hand Sanitizer 110mL (4)

OSDS HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78486-220
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
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78486-220-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202006/25/2023
2NDC: 78486-220-023800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202007/23/2023
3NDC: 78486-220-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202007/23/2023
4NDC: 78486-220-04110 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202007/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202007/23/2023
Labeler - SCR Cosmetic Corporation (105198663)
Establishment
NameAddressID/FEIBusiness Operations
SCR Cosmetic Corporation105198663manufacture(78486-220)

Revised: 9/2021
Document Id: cd16d59c-688c-324b-e053-2995a90a3374
Set id: a71182a1-b081-ce14-e053-2995a90a09cd
Version: 7
Effective Time: 20210928