DOP HAND SANITIZER- alcohol gel

DOP Hand Sanitizer by

Drug Labeling and Warnings

DOP Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Omega & Delta Co, Omega & Delta. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

INDICATIONS & USAGE

Uses: For handwashing to decrease bacteria on the skin.

Warnings:

For external use only

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.

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.

DOSAGE & ADMINISTRATION

Directions:  Wet hands thoroughly with product and allow to dry without wiping.  Use only under adult supervision.  Not recommended for infants.

OTHER SAFETY INFORMATION

Other Information:  Do not store above 105o F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

INACTIVE INGREDIENT

Inactive Ingredients:  Water, Glycerin, propylene Glycol, carbomer, Fragrance, and Triethanolamine

SPL UNCLASSIFIED SECTION

Hecho en Puerto Rico por:

Omega & Delta Co., Inc.P.O. Box 1449, Carolina, P.R. 00984

PRINCIPAL DISPLAY PANEL

DOP

Instant

Hand

Sanitizer

with

Moisturizers

Original

KILLS 99.9% of GERMS

8 FL. OZ. (237 ml)

INGREDIENTS AND APPEARANCE

DOP HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51048-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51048-027-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/09/2009
2	NDC: 51048-027-08	273 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/09/2009

Labeler - Omega & Delta Co (090317793)

Establishment
Name	Address	ID/FEI	Business Operations
Omega & Delta		090317793	manufacture(51048-027)