MELI HANDS HAND SANITIZER- ethyl alcohol spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
MELI HANDS, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic To help reduce bacteria on the skin.
Authorization status:
OTC monograph not final
Authorization number:
79426-105-01, 79426-105-02, 79426-105-08, 79426-105-16

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MELI HANDS HAND SANITIZER- ethyl alcohol spray

MELI HANDS, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

MELI HANDS HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

To help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from flame or high heat.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develop.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

immediately.

Directions

Spray or pump a small amount into the palm of your dry hands, rub and wait until evaporated. Children

under 6 should be supervised when using this product.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Benzoate Natural, Ethyl Butyrate Natural, Gamma Octalactone

Natural, Glycerin, Heliotropine Natural, Hexyl Acetate Natural, Isopropyl Myristate, Neobee M-5

Natural Solvent, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Peppermint Oil,

Tocopheryl Acetate, Vanillin Natural, Water

Questions or Comments

info@melihands.com

ALOE VERA + ESSENTIAL OILS

FROSTED PEPPERMINT

Meli Hands, LLC Dallas, TX 75248 www.melihands.com

Packaging

MELI HANDS HAND SANITIZER

ethyl alcohol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:79 426 -10 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

70 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

ETHYL BUTYRATE (UNII: UFD2LZ0 0 5D)

.GAMMA.-O CTALACTO NE (UNII: UHD6 M52X0 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

PIPERO NAL (UNII: KE10 9 YAK0 0 )

HEXYL ACETATE (UNII: 7U7KU3MWT0 )

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

ACRYLATES/VINYL ISO DECANO ATE CRO SSPO LYMER ( 10 0 0 0 MPA.S NEUTRALIZED AT 0 .5%) (UNII:

2N8 MDB79 NA)

MELI HANDS, LLC

2N8 MDB79 NA)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

VANILLIN (UNII: CHI530 446 X)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:79 426 -10 5-

30 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/13/20 20

2

NDC:79 426 -10 5-

6 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/13/20 20

3

NDC:79 426 -10 5-

237 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/13/20 20

4

NDC:79 426 -10 5-

473 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/13/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

11/13/20 20

Labeler -

MELI HANDS, LLC (117561450)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MELI HANDS, LLC

11756 1450

ma nufa c ture (79 426 -10 5)

Revised: 11/2020

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