ANTI BACTERIAL 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:
Dolgencorp Inc.
INN (International Name):
ALCOHOL
Composition:
ALCOHOL 62 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Antiseptic Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours. Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.
Authorization status:
OTC monograph not final
Authorization number:
55910-988-47

ANTI BACTERIAL HAND SANITIZER- ethyl alcohol gel

Dolgencorp 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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Active Ingredients:

Ethyl Alcohol 62%

Purpose:

Antiseptic

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears or mouth.

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

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

Directions:

Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Inactive ingredients: Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe

Barbadenis Leaf Juice

Other information: Do not store in temperature over 118 F.

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available.

Recommended for repeated use.

ANTI BACTERIAL HAND SANITIZER

ethyl alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -9 8 8

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

WATER (UNII: 0 59 QF0 KO0 R)

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

Dolgencorp Inc.

GLYCERIN (UNII: PDC6 A3C0 OX)

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

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:559 10 -9 8 8 -

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

Pro duc t

0 2/22/20 16

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 2/22/20 16

Labeler -

Dolgencorp Inc. (068331990)

Revised: 2/2016

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