NATUREDROPS HAND SANITIZER 80%- ethyl alcohol gel

NatureDrops Hand Sanitizer 80% by

Drug Labeling and Warnings

NatureDrops Hand Sanitizer 80% by is a Otc medication manufactured, distributed, or labeled by Bioplasticos y Polimeros BIOFASE, S.A.P.I. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredient(s)

Ethyl Alcohol at 80% (v/v)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses: Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

WARNINGS: For external use only, Flammable. Keep away from open flame and sources of heat or flame.

Do not use: In children less than 2 months of age. On open skin wounds.

When using this product: Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse

immediately with plenty of water and seek medical advice.

Stop use and ask a doctor: If an irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children: If swallowed, seek medical advice or contact a poison control center right away.

DOSAGE & ADMINISTRATION

DIRECTIONS: Place enough product on hands to cover all surfaces and rub between both side of hands until dry. Children under 6 years of age should be supervised when using this product to avoid swallowing.

STORAGE AND HANDLING

Other information: Store between 15-30°C (59-86°F). Avoid freezing and excessive heat above 40°C (104°F). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Carbomer, Glycerin, Aminomethyl Propanol, Peppermint essential oil, Menthol.

SPL UNCLASSIFIED SECTION

Products from the Earth

with Mint plant alcohol and Aloe Vera

KILLS 99.9% OF GERMS*

Ethyl Alcohol made from plant sugars.

Enriched with alcohol obtained from mint plant.

With moisturizing Aloe Vera.

Plant based fragrance.

Non-sterile and topical solution.

*Effective at eliminating 99.9% of many common germs and bacteria.

RESPONSE: If inhaled: Remove person to fresh air and keep comfortable for breathing.

Call a doctor if you feel unwell. If in eyes: Rinse cautiously with water for several minutes.

Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention.

In case of fire: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide for extintion.

DANGER: Highly flammable liquid and vapor. Causes serious eye irritation. May cause drowsiness or dizziness. Store below 110ºF (43ºC).

PREVENTION: Keep away from heat, sparks, and open flames. No smoking. Keep container tightly closed. Avoid breathing vapors.

CONTACT US:

www.thenaturedrops.com

help@thenaturedrops.com

+52 8113634206

thenaturedrops

MANUFACTURED AND EXPORTED BY:

Bioplásticos y Polímeros Biofase SAPI de CV. Madero Oriente No. 6500

Int. 209, Ciudad Industrial, Morelia, Michoacán 58200, México (MEX).

Do not pollute, dispose of the used product appropriately.

Packaging

INGREDIENTS AND APPEARANCE

NATUREDROPS HAND SANITIZER 80% 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77452-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77452-004-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2020
2	NDC: 77452-004-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 77452-004-60	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Bioplasticos y Polimeros BIOFASE, S.A.P.I. de C.V. (951577065)

Establishment
Name	Address	ID/FEI	Business Operations
Bioplasticos y Polimeros BIOFASE, S.A.P.I. de C.V.		951577065	manufacture(77452-004)