GLYTONE ACNE- salicylic acid 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.

----------

Glytone Acne Treatment Lotion

Drug Facts

Active Ingredients

Salicylic Acid 1 %

Purpose

Acne Treatment

Use

For the treatment of acne.

  • Clears up acne pimples, blackheads and whiteheads.
  • Helps keep skin clear of new acne blemishes and allows skin to heal.

Warnings

For external use only.

  • Using other topical acne medications at the same time or immediately following use of the product may cause increased dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by your physician.

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 the eyes. If eye contact occurs, flush thoroughly with water.

Keep out of reach of children.

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

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Cover the affected area(s) with a thin layer one to three times daily, or as directed by your physician.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by your physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

 Store at room temperature of 68-77° F (20-25° C).

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ethoxydiglycol, Propylene Glycol, Glyceryl Laurate, PEG-100 Stearate, Cyclopentasiloxane, Cetearyl Glucoside, Behenyl Alcohol, Bisabolol, Carnosine, Hydrogenated Lecithin, Oryza Sativa (Rice) Bran Extract, Xanthan Gum, Sodium Hydroxide, Polysilicone-11, Disodium EDTA, Methylparaben, Ethylparaben, Butylparaben, Dimethylacrylamide/Acrylic Acid Ethyl Methacrylate copolymer, propylparaben, isobutylparaben, phenoxyethanol

Principal Display Panel

label

Glytone Acne

treat

acne lotion

1% salicylic acid

non-irritating formula

60 ml/2 fl.oz

GLYTONE ACNE 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL LAURATE (UNII: Y98611C087)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
DOCOSANOL (UNII: 9G1OE216XY)  
LEVOMENOL (UNII: 24WE03BX2T)  
CARNOSINE (UNII: 8HO6PVN24W)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
RICE BRAN (UNII: R60QEP13IC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-300-011 in 1 CARTON10/12/201011/11/2017
160 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 FINALpart333D10/12/201011/11/2017
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2016
Document Id: 6ade64df-f222-424a-a865-bcf754e9e6ab
Set id: dce7b18f-b9ab-423b-8db4-596d838ba990
Version: 5
Effective Time: 20160803
 
Genesis Pharmaceutical, Inc.