HAND SANITIZER 8OZ by Pocket Nurse Enterprises, Inc.

Drug Details [pdf]

HAND SANITIZER 8OZ- ethyl alcohol gel
Pocket Nurse Enterprises, 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 70 percent

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease.
recommended for repeated use

Warnings

For external use only - hands

Flammable. Keep away from heat and flame.

When using this product

Keep out of eye. In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping.
for children under 6, use only under adult supervision.
not recommended for infants

Other information

do not store above 105 Fahrenheit
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients:

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E).

label

HAND SANITIZER 8OZ
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77629-131
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 77629-131-01	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2020

Labeler - Pocket Nurse Enterprises, Inc. (805742434)

Registrant - Pocket Nurse Enterprises, Inc. (805742434)

Revised: 6/2020

Document Id: a7a4eebf-a995-6443-e053-2a95a90aff4b

Set id: a7a4eebf-a994-6443-e053-2a95a90aff4b

Version: 1

Effective Time: 20200601