Glytone Acne Back

Dosage form: spray
Ingredients: SALICYLIC ACID 20mg in 1mL
Labeler: Genesis Pharmaceutical, Inc.
NDC Code: 64760-213

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.

Glytone Acne Back Spray Salicylic Acid 2%

Drug Facts

Active Ingredients

Salicylic Acid 2.0%

Purpose

Acne Treatment

Use

For the treatment of acne.

  • penetrates pores to control acne blemishes.
  • helps keep skin clear of new acne blemishes.

Warnings

For external use only

Flammable: Keep away from fire or flame

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 use only one topical acne medication at a time
  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
  • apply to affected area only.
  • do not use on broken skin.
  • do not apply to large areas of the body.
  • spray in a well ventilated area. Do not inhale.

Stop use and ask a doctor if
  • rash or irritation develops and lasts.

Keep out of reach of children.

Sunburn Alert
  • Avoid unnecessary sun exposure and use a sunscreen.

Directions
  • Clean the skin thoroughly before applying this product.
  • Apply by holding the product 3 to 6 inches away from the skin.
  • Spray directly onto the affected areas of the back and shoulders with a thin layer one to three times daily.
  • Pump works upside down to secure application.
  • 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

Benzalkonium Chloride, Isopropyl Alcohol, Polysorbate 20, Water

Principal Display Panel - 240 mL Carton

 GLYTONE

ACNE

acne treatment

back spray

2% SALICYLIC ACID

240 mL / 8 FL. OZ.

GLYTONE ACNE BACK 
salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-213
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
POLYSORBATE 20 
WATER 
Packaging
#Item CodePackage Description
1NDC:64760-213-011 BOTTLE, SPRAY in 1 BOX
1240 mL in 1 BOTTLE, SPRAY
2NDC:64760-213-021 BOTTLE, SPRAY in 1 BOX
260 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D04/01/2010
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 08/2014
 
Genesis Pharmaceutical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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