622cc3f6-81b8-4bae-89bf-cc414a1090c4

SPL v1
SPL
SPL Set ID 622cc3f6-81b8-4bae-89bf-cc414a1090c4
Route
topical
Published
Effective Date 2014-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 mL)
Inactive Ingredients
water glycerin propylene glycol carbomer interpolymer type a (allyl sucrose crosslinked) aminomethylpropanol aloe vera leaf lactose cellulose, microcrystalline sucrose starch, corn ultramarine blue .alpha.-tocopherol acetate hypromelloses fd&c blue no. 1 fd&c yellow no. 5 d&c red no. 33 fd&c red no. 4

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-11-12

Description

Active Ingredients Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Active Ingredient
Active Ingredients
Ethyl Alcohol 62%

Indications and Usage

Use: To help reduce bacteria on the skin

Dosage and Administration
Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly unitl dry. Children under 6 years old should be supervised when using this product.                                                                                                                                                                           

Other Information:

Store below 118 F



Description

Active Ingredients Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

Section 51945-4
Section 55105-1
Purpose

Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Active Ingredient (55106-9)
Active Ingredients
Ethyl Alcohol 62%

Indications and Usage (34067-9)

Use: To help reduce bacteria on the skin

Dosage and Administration (34068-7)
Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly unitl dry. Children under 6 years old should be supervised when using this product.                                                                                                                                                                           

Other Information:

Store below 118 F



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

Antiseptic

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)