FDA Label for Natural Sense
View Indications, Usage & Precautions
Natural Sense Product Label
The following document was submitted to the FDA by the labeler of this product International General Trading Corp. 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)
ETHYL ALCOHOL 75%
Purpose
Antiseptic, Hand Sanitizer
Use
Decreases bacteria on skin
Recommended for repeat use
Warnings
-Extremely flammable aerosol, keep away from fire and flame
-Keep away from heat, hot surfaces, open flames and other ignition sources
-Pressurized container. Do not pierce or burn even after use
-Protect from sunlight
-For external use only
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
-IRRITATION PERSIST
OR IF PRODUCT IS SWALLOWED
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
-SHAKE WELL BEFORE USE
HOLD CAN UPRIGHT AT 6-7 INCHES AWAY FROM SURFACE AND SPRAY EVENLY
ALLOW TO AIR DRY FOR 5-10 MINUTS REPEAT IF NECCESARRY
SUPERVISE CHILDREN UNDER 6 YEARS
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
BUTANE, PROPANE, ISO BUTANE, FRAGANCE
Package Label - Principal Display Panel
550 ML 78440-001-01
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