Drug Labeling and Warnings

Drug Details [pdf]

KERALYT- salicylic acid shampoo 
Summers Laboratories Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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WARNINGS

FOR EXTERNAL USE ONLY

Keralyt Shampoo carton

Keralyt Shampoo label

Keralyt Shampoo sample

KERALYT 
salicylic acid shampoo
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 11086-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURATE (UNII: 50IRX6VLIF)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
POLYQUATERNIUM-22 (4500 MPA.S) (UNII: H3W1D31JAR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11086-152-551 in 1 BOX10/30/201309/03/2019
1NDC: 11086-152-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/30/201309/03/2019
Labeler - Summers Laboratories Inc (002382612)
Establishment
NameAddressID/FEIBusiness Operations
Summers Laboratories Inc002382612manufacture(11086-152) , pack(11086-152)

Revised: 10/2019
Document Id: d416d507-b1ab-4cf6-86f4-605efe7bc75b
Set id: 67da2666-d78f-4c50-aea0-d76899866dfa
Version: 8
Effective Time: 20191030