drug facts

drug facts
SPL v1
SPL
SPL Set ID 8f750839-bcb9-499c-8a61-ea8c4a0d296d
Route
topical
Published
Effective Date 2012-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-09-25

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%


Medication Information

Warnings

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

Uses

TO DECREASE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

Directions

WET ANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information

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

Description

ETHYL ALCOHOL 65%

Section 51945-4

Active Ingredient

ETHYL ALCOHOL 65%

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).

Keep Out of Reach of Children

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


Structured Label Content

Warnings (WARNINGS)

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

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

WET ANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information (OTHER INFORMATION)

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

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Inactive Ingredients: (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).

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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