DSC Hand Sanitizer with 70% Alcohol

DSC Hand Sanitizer with 70 Alcohol by

Drug Labeling and Warnings

DSC Hand Sanitizer with 70 Alcohol by is a Otc medication manufactured, distributed, or labeled by Crystalline Heath & Beauty From The DEad Sea LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DSC HAND SANITIZER WITH 70 ALCOHOL- alcohol soap 
Crystalline Heath & Beauty From The DEad Sea LTD

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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DSC Hand Sanitizer with 70% Alcohol

Drug Facts

Active ingredient[s]

Alcohol 70% v/v

Purpose

Antiseptic

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

avoid contact with eyes, ears and mouth. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor 

if irritaion or redness develop and persists.

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 ot avoid swallowing.

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

Inactive ingredients:

Water/Aqua, Glycerin, Carbomer, Triethanolamine.

Package Labeling:

DSC HAND SANITIZER WITH 70 ALCOHOL 
alcohol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71095-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71095-010-00	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020	12/31/2022

Labeler - Crystalline Heath & Beauty From The DEad Sea LTD (600582704)

Establishment
Name	Address	ID/FEI	Business Operations
Crystalline Heath & Beauty From The DEad Sea LTD		600582704	manufacture(71095-010)

Revised: 6/2022

Document Id: e06a0c6a-1aa2-698d-e053-2a95a90a0c8e

34390-5

Set id: 4aa2ba6a-389f-4f42-8bbe-df523d6536b1

Version: 2

Effective Time: 20220601

 

Crystalline