KERALYT 3 PERCENT- salicylic acid gel

Keralyt by

Drug Labeling and Warnings

Keralyt by is a Otc medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

SALICYLIC ACID 3%

PURPOSE

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS

INDICATIONS & USAGE

USES

HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

• FLAKING
• SCALING
• REDNESS
• IRRITATION
• ITCHING

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

ASK DOCTOR

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

DOSAGE & ADMINISTRATION

DIRECTIONS

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KERALYT  3 PERCENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11086-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11086-038-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/30/2013

Labeler - Summers Laboratories Inc (002382612)

Establishment
Name	Address	ID/FEI	Business Operations
Summers Laboratories Inc		002382612	manufacture(11086-038) , pack(11086-038)