RxNorm Names

Review RxNorm Normal Forms

ANTI-BACTERIAL HAND BERRY TWINKLE (alcohol) gel
[Bath & Body Works, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1970fe58-7bc5-43f8-b14a-34a1fa4ede29

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

ACTIVE INGREDIENT

Alcohol 68%

PURPOSE

Antiseptic

USE

Decrease bacteria on hands.

WARNINGS

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develop or increase.

FLAMMABLE

Keep away from flame or high heat.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Rub a dime sized drop into hands.

INACTIVE INGREDIENTS

Water (Aqua, Eau), Isopropyl Alcohol, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Elaeis Guineensis (Palm) Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Wheat Amino Acids, Carbomer, Lactose, Cellulose, Hydroxyethyl Urea, Hydroxypropyl Methylcellulose, Glycerin, Aminomethyl Propanol, Isopropyl Myristate, Ultramarines (CI 77007).

PRODUCT PACKAGING

MM1

ANTI-BACTERIAL HAND BERRY TWINKLE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62670-4175
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	68 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Packaging
#	Item Code	Package Description
1	NDC:62670-4175-0	29 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/06/2012

Labeler - Bath & Body Works, Inc. (878952845)

Establishment
Name	Address	ID/FEI	Business Operations
Tri-Tech Laboratories, Inc.		792844680	manufacture(62670-4175)

Revised: 01/2013

Document Id: 0b4be4d9-2486-49f2-9b9a-a8d550914313

Set id: 1970fe58-7bc5-43f8-b14a-34a1fa4ede29

Version: 1

Effective Time: 20130117

Bath & Body Works, Inc.

Daily Med

Current Medication Information

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