a684d1a4-556a-c686-e053-2a95a90ae586

SPL v1
SPL
SPL Set ID a684d1a4-556a-c686-e053-2a95a90ae586
Route
topical
Published
Effective Date 2020-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 mL)
Inactive Ingredients
aminomethylpropanol d&c red no. 33 hypromellose, unspecified .alpha.-lactose sucrose maltodextrin aloe vera leaf propylene glycol water glycerin carbomer interpolymer type a (55000 cps) .alpha.-tocopherol acetate starch, corn microcrystalline cellulose fd&c red no. 4 ultramarine blue

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-26

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings For external use only.

Keep out of eyes. In case of contact with eyes, flush

Active Ingredient

Active Ingredient

Ethyl Alcohol 62%

Indications and Usage

Uses Decrease bacteria on hands

Dosage and Administration

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Description

Active Ingredient Ethyl Alcohol 62%

Section 44425-7

Storage: Flammable,Avoid direct sunlight and keep away from fire.

Section 50565-1

Keep it out of reach of children.

Section 50566-9

Stop use and ask a doctor if irritation or redness develop.If swallowed,get medical help or contact a doctor right away.

Section 51727-6

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays(corn) Starch, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Maltodextrin, Ultramarines (CI77007), FD&C Red No.4(CI14700), D&C Red No.33 (CI17200)

Section 51945-4

Section 55105-1

Purpose

Antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings For external use only.

Keep out of eyes. In case of contact with eyes, flush

Active Ingredient (55106-9)

Active Ingredient

Ethyl Alcohol 62%

Indications and Usage (34067-9)

Uses Decrease bacteria on hands

Dosage and Administration (34068-7)

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Section 44425-7 (44425-7)

Storage: Flammable,Avoid direct sunlight and keep away from fire.

Section 50565-1 (50565-1)

Keep it out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop.If swallowed,get medical help or contact a doctor right away.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays(corn) Starch, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Maltodextrin, Ultramarines (CI77007), FD&C Red No.4(CI14700), D&C Red No.33 (CI17200)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)