47993-225

47993-225
SPL v5
SPL
SPL Set ID a2d6863c-2842-ef0d-e053-2995a90a33c1
Route
TOPICAL
Published
Effective Date 2020-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (13.8 g)
Inactive Ingredients
Water Carbomer 940 Aloe Vera Leaf Triethanolamine Benzoate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-09

Description

Active ingredients Ethyl Alcohol 68%


Medication Information

Warnings and Precautions

Warnings:

For external use only-hands.Flammable.Keep away from heat and flame. Keep out of reach of children.

Indications and Usage

Uses:

To decrease bacteria and germs on the skin.

Recommended for repeated use.

Dosage and Administration

Directions:

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

For children under 6,use only under adult supervision.

Not recommended for infants.

Description

Active ingredients Ethyl Alcohol 68%

Section 50565-1

Keep out of reach of children. For children under 6,use only under adult supervision.

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 50569-3

In case of accidental

ingestion,seek professional assistance or contact a Poison Control Center immediately

Section 51727-6

Inactive Ingredients:

Water(Aqua),Carbomer,Triethanolamine,Glycerin and Fragrance

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 68%

Section 60561-8

Do not store above 105 ℉

May discolor some fabrics

Harmful to wood finishes and plastics


Structured Label Content

Indications and Usage (34067-9)

Uses:

To decrease bacteria and germs on the skin.

Recommended for repeated use.

Dosage and Administration (34068-7)

Directions:

Wet hands thoroughly with product 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. Keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children. For children under 6,use only under adult supervision.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 50569-3 (50569-3)

In case of accidental

ingestion,seek professional assistance or contact a Poison Control Center immediately

Section 51727-6 (51727-6)

Inactive Ingredients:

Water(Aqua),Carbomer,Triethanolamine,Glycerin and Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 68%

Section 60561-8 (60561-8)

Do not store above 105 ℉

May discolor some fabrics

Harmful to wood finishes and plastics


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)