FDA Label for Simpurity Hand Sanitizer
View Indications, Usage & Precautions
- SIMPURITY 75% ALCOHOL HAND SANITIZER
- ACTIVE INGREDIENT(S)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- 74069-002-08 240 ML PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
- 74069-002-04 PRINCIPAL DISPLAY PANEL
Simpurity Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Truesdell Manufacturing & Consulting, Llc. 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.
Simpurity 75% Alcohol Hand Sanitizer
This is a hand sanitizer manufactured according to the 1994 tentative final monograph for consumer antiseptics.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- hydroxyethylcellulose
- aloe powder
- propylene glycol
- hyaluronic acid
- tea tree essential oil
- vitamin E
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. The product has undergone finished formulation product testing (kill study) to confirm effifacy and safety.
Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Uses
Helps reduce bacteria on the skin 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
Otc - When Using
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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
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
distilled water
hydroxyethylcellulose
aloe powder
propylene glycol
hyaluronic acid
tea tree essential oil
vitamin E
74069-002-08 240 Ml Package Label - Principal Display Panel
240 mL NDC: 074069-002-08
74069-002-04 Principal Display Panel
120 mL NDC: 074069-002-04
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