drug facts

drug facts
SPL v1
SPL
SPL Set ID f4badb36-ecc8-45e1-a220-f19c657ec130
Route
topical
Published
Effective Date 2011-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 mL)
Inactive Ingredients
water glycerin isopropyl myristate propylene glycol .alpha.-tocopherol acetate, d- aminomethylpropanol carbomer 934 fd&c red no. 4 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-10-05

Purpose

ANTIMICROBIAL

Description

ETHYL ALCOHOL 62%


Medication Information

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE KEEP AWAY FROM FIRE OR FLAME.

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose

ANTIMICROBIAL

Directions
  • APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.
  • CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information

DO NOT STORE ABOVE 110OC (43 OC).  MAY DISCOLOR CERTAIN FABRICS OR SURFACES.

Inactive Ingredients

WATER, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE, RED 4 (CI 14700), YELLOW (CI 19140).

Description

ETHYL ALCOHOL 62%

Section 51945-4

Active Ingredient

ETHYL ALCOHOL 62%

When Using This Product

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Keep Out of Reach of Children

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Stop Using This Product and Ask Doctor If

IRRITATION OR RASH DEVELOPS AND LASTS.


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE KEEP AWAY FROM FIRE OR FLAME.

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTIMICROBIAL

Directions (DIRECTIONS)
  • APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.
  • CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information (OTHER INFORMATION)

DO NOT STORE ABOVE 110OC (43 OC).  MAY DISCOLOR CERTAIN FABRICS OR SURFACES.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE, RED 4 (CI 14700), YELLOW (CI 19140).

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

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

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR RASH DEVELOPS AND LASTS.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)