Antibacterial Hand Wash: Package Insert and Label Information

ANTIBACTERIAL HAND WASH- silver solution
Fujian Mengjiaolan Daily Chemical Co., 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.

The Hand Wash is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) :

  1. SILVER 0.18mg/300ml
  2. SODIUM LAURETH SULFATE
  3. SORBITOL
  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)

SILVER 0.18mg/300ml 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

SODIUM LAURETH SULFATE, SORBITOL, purified water USP

Package Label — Principal Display Panel

300 mL NDC: 74531-002-01

300300
ANTIBACTERIAL HAND WASH
silver solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74531-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILVER (SILVER) SILVER 0.18 mg in 300 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURETH SULFATE
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74531-002-01 300 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/30/2020
Labeler — Fujian Mengjiaolan Daily Chemical Co., Ltd. (546632451)
Establishment
Name Address ID/FEI Operations
Fujian Mengjiaolan Daily Chemical Co., Ltd. 546632451 manufacture (74531-002)

Revised: 03/2020 Fujian Mengjiaolan Daily Chemical Co., Ltd.

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