ACNOTEX ACNE TREATMENT- resorcinol and sulfur lotion 
Genesis Pharmaceutical, 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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Acnotex

Active Ingredients

Sulfur 8%

Resorcinol 2%

Purpose

Antiacne

Uses

for the management of acne

  • Penetrates pores to control acne blemishes, acne pimples, blackheads and whiteheads
  • helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads

Warnings

For external use only

Flammable. Keep away from fire or flame

Do not use

  • on broken skin
  • on large areas of the body

When using this product

  • apply to affect area only
  • do not get into eyes
  • 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.

Stop use and ask a doctor if

  • excessive irritation develops or increases

Keep out of reach of children.

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

Directions

  • shake well
  • cleanse he skin thoroughly before applying the 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 doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

purified, water, isopropyl alcohol, propylene glycol, acetone, titanium dioxide, magnesium aluminum silicate, iron oxides, octoxynol-9, chloroxylenol, xanthan gum, fragrance

Questions? 1-800-423-5173

Monday through Friday 8:00 a.m. -4:30 p.m. Eastern Standard Time

Genesis Pharmaceutical, Inc.

Parsippany, NJ 07054

www.genesispharm.com

Made in USA

labelGenesis Pharmaceutical

Acnotex acne treatment lotion

2 fl oz. (59.14 ml)

ACNOTEX ACNE TREATMENT 
sulfur resorcinol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL20 mg  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ACETONE (UNII: 1364PS73AF)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-019-011 in 1 CARTON
159.14 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D07/07/201103/01/2015
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2015
Document Id: a139b482-2f8b-4654-b814-0bfb3d6cb9bf
Set id: 89bc8aff-8cd7-41ed-8619-11cd2dd5ffde
Version: 4
Effective Time: 20150811
 
Genesis Pharmaceutical, Inc.