NDC Code(s) : 57337-081-01
Packager : Rejoice International Corp.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne wash facial cleanser Tea tree oilSalicylic Acid LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-081
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 ACID2 g in 200 mL
Inactive Ingredients
Ingredient Name Strength
MELALEUCA ALTERNIFOLIA LEAF(UNII: G43C57162K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57337-081-01200 mL in 1 BOTTLE Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 08/01/2016

LABELER - Rejoice International Corp.(078741245)

Establishment
Name Address ID/FEI Business Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(57337-081)

PRINCIPAL DISPLAY PANEL

LABEL