FDA Label for Ec Pure Instant Cream Hand Sanitizer Unscented
View Indications, Usage & Precautions
Ec Pure Instant Cream Hand Sanitizer Unscented Product Label
The following document was submitted to the FDA by the labeler of this product Ec Labs Inc.. 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 is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
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) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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)
Alcohol 63% w/w Purpose: Antimicrobial
Use
Eliminates bacteria and germs.
Warnings
Flammable. Keep away from open flame and sources of heat. This product is intended for external use only.
Do Not Use
Do not use on children less than 2 months of age and on open wounds.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use if irritation or redness occurs and consult a doctor.
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
Apply a small amount to hands and spread evenly.
Rub thoroughly into hands for at least 30 seconds.
Allow to dry.
For occasional and personal use.
Supervise children under 6 years of age when using this product.
Other Information
- Store between 59-86F
- Avoid freezing and excessive heat above 104F
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Purpose
Antimicrobial. Hand sanitizer.
Package Label - Principal Display Panel
60g NDC: 76555-006-01
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