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Keralyt 3 PERCENT

Dosage form: gel
Ingredients: SALICYLIC ACID 3g in 100g
Labeler: Summers Laboratories Inc
NDC Code: 11086-038

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.

ACTIVE INGREDIENT

SALICYLIC ACID 3%

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS

USES

HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

  • FLAKING
  • SCALING
  • REDNESS
  • IRRITATION
  • ITCHING´╗┐

WARNINGS

FOR EXTERNAL USE ONLY

ASK A DOCTOR BEFORE USE IF CONDITION COVERS A LARGE AREA OF THE BODY

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF IRRITATION PERSISTS, CONSULT A DOCTOR.

STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE.

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

FLAMMABLE

DIRECTIONS

  • APPLY TO AFFECTED AREA ONE TO FOUR TIMES DAILY OR AS DIRECTED BY A DOCTOR.

INACTIVE INGREDIENTS

PROPYLENE GLYCOL, SD-40 ALCOHOL (21%), WATER, HYDROXYPROPYLCELLULOSE

KERALYT  3 PERCENT
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-038
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
ALCOHOL 
HYDROXYPROPYL CELLULOSE 
WATER 
Packaging
#Item CodePackage Description
1NDC:11086-038-111 TUBE in 1 BOX
1NDC:11086-038-0128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/30/2013
Labeler - Summers Laboratories Inc (002382612)
Establishment
NameAddressID/FEIOperations
Summers Laboratories Inc002382612manufacture(11086-038), pack(11086-038)

Revised: 09/2017
 
Summers Laboratories 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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