Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 847c2ebd-72c9-4113-8f34-1502a8f72b7f
Route
TOPICAL
Published
Effective Date 2010-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (.30 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-07-21

Description

Triclosan


Medication Information

Warnings and Precautions

Warnings  For external use only

Description

Section 42229-5
Directions   Wet hands. Apply palmful to hands.  Scrub thoroughly for 30 seconds. Rinse.
Section 50565-1

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

Section 50567-7

When using this product  Do not get into eyes.  If contact occurs, rinse eyes throughly with water.

Section 51727-6
Inactive Ingredients  Water (Aqua, Eau), Sodium Laureth Sulfate, Glycerine, SD Alcohol 40B, Lauramide DEA, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Extract, Tetrasodium EDTA, Isopropyl Alcohol, Benzophenone-4, Polyethylene, Microcrystalline Wax, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Methylchloroisothiazolinone, Methylisothaizolinone. May Contain: Ultramarines (Cl 77007), Yellow 5 (Cl 19140), Yellow 6 (CL 15985), Yellow 10 (Cl 47005), Red 33 (Cl 17200), Red 4 (Cl 14700), Red 40 (Cl 16035), Blue 1 (Cl 42090), Green (Cl 42053), Ext. Violet (Cl 60730).



Section 51945-4

Section 55105-1

Purpose  Antiseptic

Uses   For handwashing to decrease bacteria on the skin.

Active Ingredient

Triclosan


Structured Label Content

Warnings and Precautions (34071-1)

Warnings  For external use only

Description (34089-3)

Section 42229-5 (42229-5)
Directions   Wet hands. Apply palmful to hands.  Scrub thoroughly for 30 seconds. Rinse.
Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product  Do not get into eyes.  If contact occurs, rinse eyes throughly with water.

Section 51727-6 (51727-6)
Inactive Ingredients  Water (Aqua, Eau), Sodium Laureth Sulfate, Glycerine, SD Alcohol 40B, Lauramide DEA, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Extract, Tetrasodium EDTA, Isopropyl Alcohol, Benzophenone-4, Polyethylene, Microcrystalline Wax, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Methylchloroisothiazolinone, Methylisothaizolinone. May Contain: Ultramarines (Cl 77007), Yellow 5 (Cl 19140), Yellow 6 (CL 15985), Yellow 10 (Cl 47005), Red 33 (Cl 17200), Red 4 (Cl 14700), Red 40 (Cl 16035), Blue 1 (Cl 42090), Green (Cl 42053), Ext. Violet (Cl 60730).



Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose  Antiseptic

Uses   For handwashing to decrease bacteria on the skin.

Active Ingredient

Triclosan


Advanced Ingredient Data


Raw Label Data

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