Antibacterial Plum Foam: Package Insert and Label Information

ANTIBACTERIAL PLUM FOAM- triclosan liquid
GOJO Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Triclosan 0.3%

Purpose

Antimicrobial

Uses

  • Handwash to help decrease bacteria on the skin
  • Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet hands
  • Apply a small amount of product and work into a lather
  • Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Alcohol, Lauric Acid, Propylene Glycol, Ethanolamine, Disodium Cocoamphodiacetate, Isopropyl Alcohol, Polyquaternium-10, Prunus Domestica Fruit Extract, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200)

Product Label
(click image for full-size original)

ANTIBACTERIAL PLUM FOAM
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-540
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.003 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
LAURIC ACID
PROPYLENE GLYCOL
ETHANOLAMINE HYDROCHLORIDE
DISODIUM COCOAMPHODIACETATE
ISOPROPYL ALCOHOL
POLYQUATERNIUM-10 (400 CPS AT 2%)
PLUM
SODIUM METABISULFITE
SODIUM SULFITE
EDETATE SODIUM
SODIUM SULFATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C BLUE NO. 1
D&C RED NO. 33
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21749-540-97 700 mL in 1 BOTTLE None
2 NDC:21749-540-08 236 mL in 1 BOTTLE None
3 NDC:21749-540-89 1200 mL in 1 BOTTLE None
4 NDC:21749-540-90 1250 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/11/2012 12/01/2021
Labeler — GOJO Industries, Inc. (004162038)
Establishment
Name Address ID/FEI Operations
GOJO Industries, Inc. 036424534 MANUFACTURE (21749-540)

Revised: 11/2018 GOJO Industries, Inc.

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