Your browser does not support JavaScript! BELLI ACNE CONTROL SPOT TREATMENT (SULFUR) CREAM [ABT BELLI-MATERNA INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

BELLI ACNE CONTROL SPOT TREATMENT (sulfur) cream
[ABT Belli-Materna Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Belli Acne Control Spot Treatment

Active ingredient

Colloidal Sulfur 3%

Purpose

Anti-Acne Agent

Uses

  • reduces the severity of acne blemishes
  • helps prevent new acne blemishes

Warnings

For external use only. 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. Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.

When using this product

  • keep out of eyes
  • rinse with water to remove

Stop use and ask a doctor if

  • rash or skin irritation develops

Keep out of reach of children

In case of accidental ingestion, contact a Poison Control Center immediately.

Directions

  • cleanse the 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 physician
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

  • store below 77 degrees F / 25 degrees C

Inactive ingredients

Caprylyl Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Ethylhexylglycerin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium PCA, Xanthan Gum

Belli Acne Control Spot Treatment 14.75ml (42281-001-00)

InnerPackage

OuterPackage

BELLI ACNE CONTROL SPOT TREATMENT  
sulfur cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42281-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL 
CHAMOMILE 
CUCUMBER 
WATER 
ETHYLHEXYLGLYCERIN 
RADISH 
TEA TREE OIL 
POTASSIUM SORBATE 
SODIUM PYRROLIDONE CARBOXYLATE 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42281-001-001 in 1 CARTON
114.75 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/02/2012
Labeler - ABT Belli-Materna Inc (947134677)
Registrant - ABT Belli-Materna Inc (947134677)
Establishment
NameAddressID/FEIBusiness Operations
Chemolee Lab Corporation809982754manufacture(42281-001)

Revised: 3/2014
 
ABT Belli-Materna Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services