FDA Label for Ino Med 2 Hand Sanitizer
View Indications, Usage & Precautions
Ino Med 2 Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Groupe Dissan, Le. 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 80% v/v. 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
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 Ingredient
SQUALANE GW89575KF9 IACT
PANTHENOL WV9CM0O67Z IACT
AMINOMETHYLPROPANOL LU49E6626Q IACT
INULIN JOS53KRJ01 IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 59TL3WG5CO IACT
LIMONENE, (+)- GFD7C86Q1W IACT
ALPHA-TOCOPHEROL ACETATE 9E8X80D2L0 IACT
GLYCERIN PDC6A3C0OX IACT
WATER 059QF0KO0R IACT
HYALURONATE SODIUM YSE9PPT4TH IACT
FRUCTOSE, DL- 02T79V874P IACT
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