NATUREDROPS HAND SANITIZER- alcohol gel

NatureDrops Hand Sanitizer by

Drug Labeling and Warnings

NatureDrops Hand Sanitizer 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(s)

Ethyl Alcohol at 70% (v/v)

Purpose

Antiseptic.

Uses:

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 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.

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.

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 Ingredients:

Water, Aloe Barbadensis Leaf Juice, Carbomer, Peppermint essential oil, Glycerin, Aminomethyl Propanol, Menthol, Blue 1.

Packaging

INGREDIENTS AND APPEARANCE

NATUREDROPS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77452-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77452-003-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 77452-003-02	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 77452-003-23	236.58 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 77452-003-47	473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 77452-003-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

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(77452-003)