NDC Code(s) : 63433-895-95, 63433-895-08
Packager : DHC USA Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DHC Salicylic Acne TonerSalicylic Acid LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63433-895
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid(UNII: O414PZ4LPZ)
(Salicylic Acid - UNII:O414PZ4LPZ) 		Salicylic Acid50.5 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Butylene Glycol(UNII: 3XUS85K0RA)
Sodium Hydroxide(UNII: 55X04QC32I)
Phenoxyethanol(UNII: HIE492ZZ3T)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
Edetate Disodium(UNII: 7FLD91C86K)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
rosemary oil(UNII: 8LGU7VM393)
Green Tea Leaf(UNII: W2ZU1RY8B0)
Royal Jelly(UNII: L497I37F0C)
Scutellaria Baicalensis Root(UNII: 7J95K7ID2S)
Perilla Frutescens Leaf(UNII: T4L5881Y68)
Houttuynia Cordata Flowering Top(UNII: RH041UUZ22)
Aloe Vera Leaf(UNII: ZY81Z83H0X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63433-895-95160 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2011
2NDC:63433-895-082.5 mL in 1 CELLO PACK Type 0: Not a Combination Product08/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 08/01/2011 07/24/2018

PRINCIPAL DISPLAY PANEL

Salicylic
Acne Toner

DHC

PRINCIPAL DISPLAY PANEL - 160 ml bottle