SANITIZER HAND AND SKIN CARE- silver chloride cream

Sanitizer Hand and Skin Care by

Drug Labeling and Warnings

Sanitizer Hand and Skin Care by is a Otc medication manufactured, distributed, or labeled by Immunetec Proof Ltd., Immunetec Proof Kft., Kedo Eurocosmetics Kft.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

Inner Package (Tube)

INGREDIENTS AND APPEARANCE

SANITIZER HAND AND SKIN CARE 
silver chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81541-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILVER CHLORIDE (UNII: MWB0804EO7) (SILVER CATION - UNII:57N7B0K90A)	SILVER CATION	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81541-001-01	1 in 1 BOX	02/10/2021
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/10/2021

Labeler - Immunetec Proof Ltd. (366839547)

Registrant - Immunetec Proof Kft. (366839547)

Establishment
Name	Address	ID/FEI	Business Operations
Immunetec Proof Kft.		366839547	manufacture(81541-001)

Establishment
Name	Address	ID/FEI	Business Operations
Kedo Eurocosmetics Kft.		427068692	manufacture(81541-001)