POMEGRANATE VANILLA SCENTED HAND SANITIZER- ethyl alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Greenbrier International, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic Uses - hand sanitizer to help decrease bacteria on the skin - recommended for repeat use DISTRIBUTED BY: GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN CHINA
Authorization status:
OTC monograph not final
Authorization number:
33992-8921-1

POMEGRANATE VANILLA SCENTED HAND SANITIZER- ethyl alcohol gel

Greenbrier International, Inc.

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.

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Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

hand sanitizer to help decrease bacteria on the skin

recommended for repeat use

Warnings

For external use only.

Flammable.

Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears and mouth

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

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

Keep out of reach of children. Children must be supervised in use of this product.

Directions

squeeze as needed into your palms and thoroughly spread on both hands.

rub into skin until dry.

Other Information

Store at 20 degrees - 25 degrees C (68 degrees to 77 degrees F)

may discolor fabrics.

Inactive Ingredients

water, propylene glycol, glycerin, fragrance, carbomer, triethanolamine, tocopheryl acetate, red 40, red

33, yellow 5, blue 1

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

POMEGRANATE VANILLA SCENTED HAND SANITIZER

POMEGRANATE VANILLA SCENTED HAND SANITIZER

ethyl alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:339 9 2-8 9 21

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

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

WATER (UNII: 0 59 QF0 KO0 R)

Greenbrier International, Inc.

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Product Characteristics

Color

pink

S core

S hap e

RECTANGLE

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:339 9 2-8 9 21-1 8 8 .8 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/17/20 19

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 rt333E

0 4/17/20 19

Labeler -

Greenbrier International, Inc. (610322518)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lab Do uce Co smetics (Shenzhen) Co ., Ltd.

529 30 318 6

ma nufa c ture (339 9 2-8 9 21)

Revised: 12/2019

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