PHARMACYS PRESCRIPTION 8OZ HAND SANITIZER- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
American Consumer Products Corp
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Antiseptic Uses - Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use. Stop use and ask a doctor if: If redness or irritation develops and persists for more than 72 hours. When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
Authorization status:
OTC monograph not final
Authorization number:
72197-011-08

PHARMACYS PRESCRIPTION 8OZ HAND SANITIZER- alcohol gel

American Consumer Products Corp

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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Pharmacy's Prescription 8OZ Hand Sanitizer

Active Ingredient

Active Ingredients: Ethyl Alcohol 62%

Purpos e

Purpose: Antiseptic

Uses - Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

Warnings - For external use only. Do not swallow.

Flammable. Keep away from fire or flame.

Do not apply around eyes. Do not use in ears & mouth.

Stop Use

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

Keep out of reach of children

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

away.

Inactive Ingredients

Inactive ingredients - water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe

barbadensis gel, carbomer, fragrance.

Directions

Directions - pump as needed into your palms and thoroughly spread on both hands.- rub into skin until

dry.

Indications & Usage Section

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

Other Information

Other Information - store at 20o C (68o to 77o F).

- may discolor fabrics.

Pharmacy's Prescription 8 OZ Label

PHARMACYS PRESCRIPTION 8OZ HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7219 7-0 11

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

American Consumer Products Corp

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

TRIETHANO LAMINE 2 -CYCLO HEXYL-4 ,6 -DINITRO PHENO LATE (UNII: N2TK31JIAH)

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

ALO E ARBO RESCENS WHO LE (UNII: 0 EF0 0 WD7LU)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L 2 -( 2 -METHYLBUTYRATE) (UNII: 3Z73C50 6 A9 )

CARBO MER HO MO PO LYMER TYPE C (UNII: 4Q9 3RCW27E)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7219 7-0 11-

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

Pro duc t

0 5/0 1/20 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 rt333A

0 5/0 1/20 19

Labeler -

American Consumer Products Corp (081101181)

Revised: 5/2019

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