FDA Label for Hyalolex Hand Sanitizer With Lavender And Zinc
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- WARNINGS
- DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- RECENT MAJOR CHANGES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL HYLOLEX HAND SANITIZER LAVENDER + ZINC SULFATE + PARABEN FREE 70% ETHYL ALCOHOL KILLS GERMS
Hyalolex Hand Sanitizer With Lavender And Zinc Product Label
The following document was submitted to the FDA by the labeler of this product India Globalization Capital. 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.
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antimicrobial
Purpose
Antiseptic, Hand Sanitizer
Warnings
For external use only. Flammable. Keep away from fire 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
- Wet hands with product and briskly rub hands together until dry
- Supervise children under 6 years of age in use of this product
Other Information
- Store at 20-25C (68-77F)
- May discolor certain abric
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Recent Major Changes
Editorial revisions to the wording
Package Label.Principal Display Panel
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.
Package Label - Principal Display Panel Hylolex Hand Sanitizer Lavender + Zinc Sulfate + Paraben Free 70% Ethyl Alcohol Kills Germs
59 mL NDC: 75540-528-02
HX-HandSanitizer-041020-Lavender2 (1).jpg
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