Label: BELLI ACNE CONTROL SPOT TREATMENT- sulfur cream
- NDC Code(s): 42281-001-00
- Packager: BODY HALO LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 21, 2023
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- Belli Acne Control Spot Treatment
- Active ingredient
- Purpose
- Uses
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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
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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
- Inactive ingredients
- Belli Acne Control Spot Treatment 14.75ml (42281-001-00)
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INGREDIENTS AND APPEARANCE
BELLI ACNE CONTROL SPOT TREATMENT
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42281-001 Route of Administration TOPICAL 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 02/01/2022 1 14.75 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 01/02/2012 Labeler - BODY HALO LLC (080337757)