BELLI ACNE CONTROL SPOT TREATMENT- sulfur cream

Belli Acne Control Spot Treatment by

Drug Labeling and Warnings

Belli Acne Control Spot Treatment by is a Otc medication manufactured, distributed, or labeled by BODY HALO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

BELLI ACNE CONTROL SPOT TREATMENT  
sulfur cream

Product 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
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)