Label Content

Label Content
SPL v1
SPL
SPL Set ID cd3179cf-df58-4412-bf7f-081cb109c2bf
Route
TOPICAL
Published
Effective Date 2010-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Alpha-tocopherol Acetate Carbomer Homopolymer Type C Trolamine Glycerin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-09-08

Description

Active Ingredient:       Ethyl Alcohol   62%


Medication Information

Warnings and Precautions


Warnings: For external use only-hands. Flammable. Keep away from heat and flame.



When using this product. Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest

Indications and Usage
Uses:    To decrease bacteria on the skin that could cause disease



Dosage and Administration


Directions: Wet hands thoroughly with products and allow to dry without wiping. For children under 6 use only under adult supervision. Not recommended for infants
Description

Active Ingredient:       Ethyl Alcohol   62%

Section 44425-7

Other Information



Do not store above 105F



May discolor some fabric



Harmful to wood finishes and plastics

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or call a poison control center right away

Section 50566-9

Stop use and see a doctor if skin irritation develops.

Section 51727-6
Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Section 51945-4

labe

Section 55105-1
Purpose:  Antiseptic
Section 55106-9
Active Ingredient:      Ethyl Alcohol   62%


Structured Label Content

Indications and Usage (34067-9)
Uses:    To decrease bacteria on the skin that could cause disease



Dosage and Administration (34068-7)


Directions: Wet hands thoroughly with products and allow to dry without wiping. For children under 6 use only under adult supervision. Not recommended for infants
Warnings and Precautions (34071-1)


Warnings: For external use only-hands. Flammable. Keep away from heat and flame.



When using this product. Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest

Section 44425-7 (44425-7)

Other Information



Do not store above 105F



May discolor some fabric



Harmful to wood finishes and plastics

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or call a poison control center right away

Section 50566-9 (50566-9)

Stop use and see a doctor if skin irritation develops.

Section 51727-6 (51727-6)
Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Section 51945-4 (51945-4)

labe

Section 55105-1 (55105-1)
Purpose:  Antiseptic
Section 55106-9 (55106-9)
Active Ingredient:      Ethyl Alcohol   62%


Advanced Ingredient Data


Raw Label Data

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