RxNorm Names

Review RxNorm Normal Forms

CARE ONE ANTIBACTERIAL TANGERINE SPICE (ethyl alcohol) liquid
[AMERICAN SALES COMPANY]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f750839-bcb9-499c-8a61-ea8c4a0d296d

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

ETHYL ALCOHOL 65%

PURPOSE

ANTISEPTIC

USES

TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

WET ANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110F (43C).

INACTIVE INGREDIENTS:

WATER (AQUA), pROPYLENE GLYCOL, CARBOMER, GLYCERIN, ISOPROPYL MYRISTATE, FRAGRANCE (PARFUM), AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, TRIETHYL CITRATE, MICA, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, TALC, TITANIUM DIOXIDE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), RED 4 (CI 14700), ORANGE 4 (CI 15510).

IMAGE OF THE LABEL

CARE ONE ANTIBACTERIAL TANGERINE SPICE
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-470
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	650 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PROPYLENE GLYCOL
CARBOMER 934
GLYCERIN
ISOPROPYL MYRISTATE
AMINOMETHYLPROPANOL
.ALPHA.-TOCOPHEROL ACETATE
TRIETHYL CITRATE
MICA
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C RED NO. 4
D&C ORANGE NO. 4

Packaging
#	Item Code	Package Description
1	NDC:41520-470-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/25/2012

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(41520-470)

Revised: 09/2012

Document Id: 5844de03-3961-49b5-b991-550e4e617390

Set id: 8f750839-bcb9-499c-8a61-ea8c4a0d296d

Version: 1

Effective Time: 20120926

AMERICAN SALES COMPANY

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