ROCCOS OLD SCHOOL TATTOO BALM ANTI BACTERIAL WASH- triclosan liquid

Roccos Old School Tattoo Balm by

Drug Labeling and Warnings

Roccos Old School Tattoo Balm by is a Otc medication manufactured, distributed, or labeled by Rocco's Old School, Creations Garden Natural Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Triclosan 0.3%...................................................Antiseptic

Use:

• To decrease bacteria on the skin that could cause disease. Recommended for repeated use.
  

Warnings:

For external use only--skin.

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.
  

Stop use and ask a doctor if

skin irritation develops.

Keep out of reach of children.

in case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Wet skin area with water.
• Apply Anti Bacterial Wash.
• Wash off thoroughly.
  

Other information

• Do not store above 105°F.
• May discolor some fabrics.
• Harmful to wood finishes and plastics.
  

Inactive ingredients

Water, Decyl Glucoside (and), Sodium Lauroyl Lactylate, Cocamidopropyl Betaine, Sodium Hyaluronate, Echinacea Purpurea Extract, Methyl Sulfonyl Methane (MSM), Lavandula Angustifolia (lavender) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract,Citrus Limonum (Lemon) Peel, Salvia Officinalis (Sage) Leaf Extract, Radish Root Ferment Filtrate, Arctostaphylos Uva Ursi (Bearberry) Extract, melaleuca Altenafolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Oil Unsaponifiables, Potassium Sorbate, SOdium Benzoate, Aminomethyl Propanol, Fragrance

Questions?

661-877-4280

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ROCCOS OLD SCHOOL TATTOO BALM  ANTI BACTERIAL WASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3.54 mL  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ECHINACEA (UNII: 4N9P6CC1DX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
ROSEMARY (UNII: IJ67X351P9)
LEMON PEEL (UNII: 72O054U628)
SAGE (UNII: 065C5D077J)
RADISH (UNII: EM5RP35463)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
TEA LEAF (UNII: GH42T47V24)
OLIVE OIL (UNII: 6UYK2W1W1E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
COCONUT (UNII: 3RT3536DHY)
LIME (UNII: C7X2M0VVNH)
VERBENA HASTATA ROOT (UNII: LJ96XN173E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-008-10	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/28/2011

Labeler - Rocco's Old School (961956229)

Registrant - Creations Garden Natural Products Inc. (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products Inc.		961956229	manufacture