BELLI ACNE CONTROL SPOT TREATMENT  - sulfur cream 
ABT Belli-Materna 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.

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Belli Acne Control Spot Treatment

Belli Acne Control Spot Treatment

Active ingredient

Colloidal Sulfur 3%

Purpose

Anti-Acne Agent

Uses

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

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

Other information

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
Document Id: 22afdb6f-8688-4eb6-b720-e7c8dc4ad56a
Set id: da979b69-1e4c-4e2b-82c3-0f155e978652
Version: 3
Effective Time: 20140327
 
ABT Belli-Materna Inc