KERALYT 5- salicylic acid gel 
Summers Laboratories 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.

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ACTIVE INGREDIENT

SALICYLIC ACID 5%

PURPOSE

SKIN SOFTENER

USES

  • HELPS EXFOLIATE ROUGH OR SCALY SKIN OR SCALP

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IF EYE CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

DO NOT USE ON IRRITATED, INFECTED OR OPEN SKIN.

STOP USE AND ASK A DOCTOR IF

  • REDNESS, DISCOMFORT OR IRRITATION OCCUR FOLLOWING USE OF THIS PRODUCT

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

FLAMMABLE

KEEP AWAY FROM HEAT AND OPEN FLAME.

DIRECTIONS

For the scalp: KERALYT® 5 GEL should be applied directly to the affected areas of the scalp. The applicator tip will provide accurate application, avoiding contact with normal or skin or hair. The gel should be washed off after 10 to 20 minutes initially, but it can be left on for up to one hour as treatment progresses, or as directed by your healthcare provider. The gel can be washed off using KERALYT ® 5 SHAMPOO or warm water in a bath or shower. Use daily until your scalp improves, then once or twice weekly or as needed.

For rough or scaly skin: Apply KERALYT® 5 GEL directly to the affected area(s) one to four times daily or as directed by your healthcare provider.

INACTIVE INGREDIENTS

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

Keralyt 5 Gel_Unit Carton

KERALYT 5 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11086-051-611 in 1 BOX10/30/201311/02/2016
1NDC:11086-051-6060 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/30/201311/02/2016
Labeler - Summers Laboratories Inc (002382612)
Establishment
NameAddressID/FEIBusiness Operations
Summers Laboratories Inc002382612manufacture(11086-051) , pack(11086-051)

Revised: 11/2016
 
Summers Laboratories Inc