SPL v1
SPL
SPL Set ID 8ce8124a-73e0-44cc-a804-9a470ba60e41
Route
TOPICAL
Published
Effective Date 2013-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (554 mL)
Inactive Ingredients
Water Propylene Glycol Polyacrylic Acid (250000 Mw) Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 57-61) Aloe Vera Leaf Tocopheryl Retinoate Disodium (ethoxycarbonyl)phosphonate Sodium Hydride Fd&c Yellow No. 5 Fd&c Blue No. 1 Fd&c Red No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-11-15

Description

ACTIVE INGREDIENT: ETHYL ALCOHOL 55.4% PURPOSE ANTISEPTIC


Medication Information

Warnings and Precautions

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

Indications and Usage

USES: TO HELP REDUCE BACTERIA ON THE HANDS.

Dosage and Administration

DIRECTIONS: WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Description

ACTIVE INGREDIENT: ETHYL ALCOHOL 55.4% PURPOSE ANTISEPTIC

Section 50565-1

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

Section 50567-7

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES AND LIPS. IF CONTACT OCCURS, RINSE WITH WATER.

Section 50569-3

STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS

Section 51727-6

INACTIVE INGREDIENTS: WATER, PROPYLENE GLYCOL, FRAGRANCE, POLYACRYLIC ACID, HYDROGENATED JOJOBA OIL, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, SODIUM HYDROXIDE. MAY CONTAIN: FD&C BLUE NO. 1(CI 42090), D&C RED NO. 33(CI 17200), FD&C RED NO. 40(CI 16035), FD&C YELLOW NO. 5 (CI 19140)

Section 55105-1

ANTISEPTIC

Miss Spa Hand Sanitiser

ACTIVE INGREDIENT: ETHYL ALCOHOL 55.4% PURPOSE ANTISEPTIC


Structured Label Content

Indications and Usage (34067-9)

USES: TO HELP REDUCE BACTERIA ON THE HANDS.

Dosage and Administration (34068-7)

DIRECTIONS: WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES AND LIPS. IF CONTACT OCCURS, RINSE WITH WATER.

Section 50569-3 (50569-3)

STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: WATER, PROPYLENE GLYCOL, FRAGRANCE, POLYACRYLIC ACID, HYDROGENATED JOJOBA OIL, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, SODIUM HYDROXIDE. MAY CONTAIN: FD&C BLUE NO. 1(CI 42090), D&C RED NO. 33(CI 17200), FD&C RED NO. 40(CI 16035), FD&C YELLOW NO. 5 (CI 19140)

Section 55105-1 (55105-1)

ANTISEPTIC

Miss Spa Hand Sanitiser

ACTIVE INGREDIENT: ETHYL ALCOHOL 55.4% PURPOSE ANTISEPTIC


Advanced Ingredient Data


Raw Label Data

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