Blemish Buster® Solution Acne Treatment

Blemish Buster by

Drug Labeling and Warnings

Blemish Buster by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLEMISH BUSTER- sulfur liquid 
THE PROACTIV COMPANY LLC

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.

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Blemish Buster® Solution
Acne Treatment

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sulfur 10.0%

Purpose

Acne Treatment

Use

for the management of acne

• dries acne blemishes and allows skin to heal.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used, unless directed by a doctor.
• If excessive skin irritation develops or increases, discontinue use and consult a doctor.
• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Directions

• Shake well before using to activate.
• Cleanse skin thoroughly before applying medication.
• Cover the entire affected area with a thin layer one to three times 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.
• Gently dust off after 60 seconds with tissue or towel.
• If product collects and clogs bottle, point bottle away from eyes when attempting to unclog.
• Do not squeeze bottle while clearing out product to unclog.

SPL UNCLASSIFIED SECTION

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Isopropyl Alcohol, Water (Aqua), Zinc Oxide, Propylene Glycol, Algae Extract, Artemisia Vulgaris Extract, Disodium Cocoamphodiacetate, Mentha Piperita (Peppermint) Oil, Dipotassium Glycyrrhizate, Menthol.

Questions?

800-510-4961

SPL UNCLASSIFIED SECTION

Distributed by Guthy-Renker®
Palm Desert, CA 92260
Toronto, Canada M1B 3W2

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Label

PRINCIPAL
SECRET ®

Blemish
Buster®
Solution

Acne Treatment

15 ml e 0.51 FL. Oz.

FRESH MINT SCENT

BLEMISH BUSTER 
sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Menthol, Unspecified Form (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-210-05	15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/11/2010	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/11/2010	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 6/2011

Document Id: 4f758a5b-caff-4fdd-ab99-fc88338fcd27

34390-5

Set id: 5bf744b2-aab7-46e7-8ded-ff762e82e299

Version: 2

Effective Time: 20110630

 

THE PROACTIV COMPANY LLC