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GlySal Clear Acne Treatment Serum

Dosage form: solution
Ingredients: Salicylic Acid 15mg in 1mL
Labeler: Edge Systems LLC
NDC Code: 70753-0201

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.

GlySal™ Clear Acne Treatment Serum

Drug Facts

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

  • 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 1 topical acne medication at a time
  • each vial is for single use only; do not refill
  • use only as directed
  • do not use entire vial for one treatment
  • do not use on damaged or broken skin or large areas of the skin
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with plenty of water
  • this product contains an alpha hydroxyl acid (AHA) that may increase skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards
  • discontinue use if irritation occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions
  • clean the skin thoroughly before applying this product
  • apply 3 mL (approximately 1/3 of the vial) evenly to cover the entire affected area no more than once a week
  • after 2 to 3 minutes, use a wet sponge to gently pat the skin where the product is applied. Do not rinse

Other information
  • store in a cool, dry place out of sunlight

Inactive ingredients

water(aqua), pentylene glycol glycerin, glycolic acid, potassium hydroxide, sodium lactate, hydroxyethylcellulose.

PRINCIPAL DISPLAY PANEL - 9 mL Vial Box

GLYSAL™ CLEAR

Acne treatment serum

GLYSAL CLEAR ACNE TREATMENT SERUM 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70753-0201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Pentylene Glycol 
Glycerin 
Glycolic Acid 
Sodium Lactate 
Potassium Hydroxide 
Hydroxyethyl Cellulose (4000 MPA.S at 1%) 
Packaging
#Item CodePackage Description
1NDC:70753-0201-16 VIAL, PLASTIC in 1 BOX
19 mL in 1 VIAL, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/01/2016
Labeler - Edge Systems LLC (364134791)

Revised: 07/2016
 
Edge Systems LLC

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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