SANITIZER HAND AND SKIN CARE- silver chloride cream 
Immunetec Proof Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Immunetec Hand Sanitizer

Active Ingredient

Silver Chloride 0.3% w/w

Purpose

Antiseptic

Uses

To help reduce the number of disease-causing bacteria, virus, and fungi until the next hand wash.

For use when soap and water are not available.

Warnings

For external use only.

Keep out of reach of children under 6 years of age.

When using this product:

  • keep out of eyes, ears, and mouth.
  • Do not ingest.
  • In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Directions

• Apply after cleansing and drying the skin surface on hand or elsewhere.

• Apply a generous amount and spread evenly to cover all surfaces.

• Can be applied regularly.

Other information or comments

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

Inactive Ingredients

Water (Aqua), Stearic acid, Glycerin, Sodium bentonite, Phenoxyethanol, Acrylate copolymer, Triethanolamine, Caprylyl glycol, Titanium dioxide

Principal Display Panel

Sanitizer Hand and Skin Care (50 mL), NDC: 81541-001-01

Outer Package (Box)

Sanitizer Hand and Skin Care

Inner Package (Tube)

Sanitizer Hand and Skin Care_Tube

SANITIZER HAND AND SKIN CARE 
silver chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81541-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILVER CHLORIDE (UNII: MWB0804EO7) (SILVER CATION - UNII:57N7B0K90A) SILVER CATION0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENTONITE (UNII: K1BPI94O04)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81541-001-011 in 1 BOX02/10/2021
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/10/2021
Labeler - Immunetec Proof Ltd. (366839547)
Registrant - Immunetec Proof Kft. (366839547)
Establishment
NameAddressID/FEIBusiness Operations
Immunetec Proof Kft.366839547manufacture(81541-001)
Establishment
NameAddressID/FEIBusiness Operations
Kedo Eurocosmetics Kft.427068692manufacture(81541-001)

Revised: 2/2021
Document Id: bb2a3f0c-1bd8-7d7c-e053-2995a90aeee0
Set id: ba73db2e-3ec8-fe92-e053-2995a90a463a
Version: 3
Effective Time: 20210212
 
Immunetec Proof Ltd.