BRODA ACNE- salicylic acid gel

BRODA Acne by

Drug Labeling and Warnings

BRODA Acne by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredient

Salicylic acid 2%

Purpose

acne treatment

Keep out of reach of children

Keep out of reach of children.

 If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Acne treatment and helps prevent new acne blemishes.

Warnings

For external use only.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Directions

• Clean the skin thoroughly before applying this product.
• 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 doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  

Inactive ingredients

Water, poloxamer 407, propylene glycol, PEG-400, laureth-4, menthol, bisabolol.

BRODA Acne Spot Treatment and Acne Treatment Pen Labels

Tough on acne

Gentle on your skin

Anti-acne IntelliGel™

BRODA Acne Spot Treatment

Broda Acne Treatment Pen

IntelliGel™ Technology
Suitable for sensitive skin

Maximum strength with 2% beta hydrox acid
Forms TrueSkin invisible patch
No peeling or flaking

Won't dry your skin

Alcohol-free Hydrogel

NET WT. 0.071 oz. (2g) - 0.71 oz. (20 g)

Distributed by:
Broda International, LLC
10 Barley Court
Plainsboro, NJ 08536
Manufactured and packaged in the USA
www.broda.com

Patent pending

BRODA™

Anti-acne IntelliGel™

Developed with a proprietary break-through IntellGel™ technology that delivers maximum strength acne medication to effectively penetrate pores to clear most acne blemishes and help prevent new acne pimples.

INGREDIENTS AND APPEARANCE

BRODA ACNE  
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.4 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
LAURETH-4 (UNII: 6HQ855798J)
MENTHOL (UNII: L7T10EIP3A)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-112-50	20 g in 1 TUBE; Type 0: Not a Combination Product	10/29/2013
2	NDC: 54111-112-51	2 g in 1 TUBE; Type 0: Not a Combination Product	10/29/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/29/2013

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-112)