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 Type HUMAN OTC DRUG Item Code (Source) NDC:42281-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 30 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
RADISH (UNII: EM5RP35463)  
TEA TREE OIL (UNII: VIF565UC2G)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42281-001-00 1 in 1 CARTON
1 14.75 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/02/2012
Labeler - ABT Belli-Materna Inc (947134677)
Registrant - ABT Belli-Materna Inc (947134677)
Establishment
Name Address ID/FEI Business Operations
Chemolee Lab Corporation 809982754 manufacture(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