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NDC 81998-0001-01 Flod Hand Sanitizer Gel, Aloha-Green Apple Scent 70 mL/100mL Details

Flod Hand Sanitizer Gel, Aloha-Green Apple Scent 70 mL/100mL

Flod Hand Sanitizer Gel, Aloha-Green Apple Scent is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Aluma Packaging Corporation, S.A. de C.V.. The primary component is ALCOHOL.

Product Information

NDC	81998-0001
Product ID	81998-001_d9cdf987-c8a5-c429-e053-2995a90ae074
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Flod Hand Sanitizer Gel, Aloha-Green Apple Scent
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Aluma Packaging Corporation, S.A. de C.V.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 81998-0001-01 (81998000101)

Pricing Information	N/A
NDC Package Code	81998-001-01
Billing NDC	81998000101
Package	12 PACKET in 1 BOX (81998-001-01) / 100 POUCH in 1 PACKET / 1.7 mL in 1 POUCH
Marketing Start Date	2020-03-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c469df98-ec0e-2c76-e053-2a95a90af006 Details

DRUG FACTS

Active Ingredient:

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial Use

Use:

Hand Sanitizer to help reduce bacteria on the skin.

Warnings:

Flammable, keep away from fire or flame. Exclusively for external use. Do not ingest, in case of accidental ingestion consult your doctor immediately. Keep away from the eyes, in case of accidental contact with eyes, rinse with water and consult your doctor. In case of irritation or redness, discontinue use, if discomfort persists consult your doctor.

Keep out of reach of children,

supervision is required for children under 6 years of age.

Directions:

Empty the contents of the packet into the palm of the hand, rub both hands until the product covers the entire surface of the hands, let it

absorb. No need to rinse, wash or dry hands.

Inactive ingredients:

Water, carbomer, triethanolamine, glycerin, Castor Oil, tocopheryl acetate, Aloe vera extract. Fragrance.

Other information:

Store below 110ºF (43ºC)

Questions or comments:

[email protected]

Package Labeling:

INGREDIENTS AND APPEARANCE

FLOD HAND SANITIZER GEL, ALOHA-GREEN APPLE SCENT

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81998-001(NDC:77739-001)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
CASTOR OIL (UNII: D5340Y2I9G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81998-001-01	12 in 1 BOX	03/23/2020
1		100 in 1 PACKET
1		1.7 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/23/2020

Labeler - Aluma Packaging Corporation, S.A. de C.V. (951614095)

Revised: 3/2022

Document Id: d9cdf987-c8a5-c429-e053-2995a90ae074

Set id: c469df98-ec0e-2c76-e053-2a95a90af006

Version: 2

Effective Time: 20220309