BELLI ACNE CONTROL SPOT TREATMENT- sulfur cream 
BODY HALO 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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BODY HALO - Belli - Acne Control Spot Treatment (42281-001)

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 DRUGItem Code (Source)NDC:42281-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42281-001-001 in 1 CARTON02/01/2022
114.75 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00601/02/2012
Labeler - BODY HALO LLC (080337757)

Revised: 2/2023
Document Id: f53988dc-9b5b-7c21-e053-2a95a90a1042
Set id: da979b69-1e4c-4e2b-82c3-0f155e978652
Version: 6
Effective Time: 20230221
 
BODY HALO LLC