BLEMISH BULLY ACNE SPOT TREATMENT- salicylic acid liquid

Blemish Bully Acne Spot Treatment by

Drug Labeling and Warnings

Blemish Bully Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Tarte Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Salicylic acid 1.5%

Purpose

Acne Treatment

Uses

• For the treatment of Acne.
• Helps keep skin clear of new acne blemishes, blackheads or whiteheads.

Warnings

For external use only.

Avoid eye and lip areas

When using this product

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Flammable, keep away from heat and flame.

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

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times a daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

• You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.

Inactive ingredients

Water, SD alcohol 40-B, butylene glycol, niacinamide, carbomer, octadecenedioic acid, phenoxyethanol, aminomethyl propanol, azelaic acid, caffeine, sodium ascorbyl phosphate, glycerin, hamamelis virginiana (witch hazel) extract, eugenia caryophyllus (clove) leaf oil, eugenol, cucumis sativus (cucumber) fruit extract, origanum vulgare leaf oil.

SPL UNCLASSIFIED SECTION

Dist. by tarte™, Inc. New York, NY 10018.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton

tarte skincare
high-performance naturals™

BLEMISH BULLY

acne spot
treatment

INGREDIENTS AND APPEARANCE

BLEMISH BULLY ACNE SPOT TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)	Salicylic acid	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
AZELAIC ACID (UNII: F2VW3D43YT)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
CLOVE LEAF OIL (UNII: VCA5491KVF)
EUGENOL (UNII: 3T8H1794QW)
CUCUMBER (UNII: YY7C30VXJT)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-125-01	1 in 1 CARTON	12/03/2017
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/03/2017

Labeler - Tarte Inc. (027905186)