FDA Label for Sanitizer Ace-sa001
View Indications, Usage & Precautions
Sanitizer Ace-sa001 Product Label
The following document was submitted to the FDA by the labeler of this product Ace Chem Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This sanitizer is manufactured using only the following United States Pharmacopoei (USP) grade ingredients in the preparation of the product (percentage in the final product formulation) consistent with World Health Organization (WHO):
Belzankonium Chloride (0.2% volume/volume (v/v)) in an aqueous solution).
Alcohol (isopropylic alcohol) (10% v/v)
Sterile distilled water or boiled cold water.
This firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Otc - Active Ingredient
Benzalkonium Chloride. Purpose: Antiseptic
Otc - Purpose
Antiseptic, Hands, Surface and Cloths Sanitizer.
Indications & Usage
Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water ar not available.
Warnings
For external use only.
Otc - Do Not Use
in children less than 2 months of age
on open skin wounds
Otc - When Using
When using this product keep out eyes, ears, 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious conditions.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Place enough product on hands or surfaces to cover all. Rub hands together untill dry.
Supervise children under 6 years of age when using this products to avoid swallowing.
Storage And Handling
Store between 15-30C (59-86F)
Avoiding freezing and excessive heat above 40C (104F)
Inactive Ingredient
Isopropylic Alcohol, purified water USP.
Package Label.Principal Display Panel
250 ml NDC: 77308-003-01
1 L NDC: 77308-003-03
4 L NDC: 77308-003-04
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