NDC Code(s) : 57687-510-25
Packager : Nelson Bach USA, Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pure and Clear Exfoliating WashArnica montana, Calendula officinalis Flowering Top, and Hypericum perforatum SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57687-510
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Arnica montana(UNII: O80TY208ZW)
(Arnica montana - UNII:O80TY208ZW) 		Arnica montana6.25 [hp_X] in 125 mL
Calendula officinalis Flowering Top(UNII: 18E7415PXQ)
(Calendula officinalis Flowering Top - UNII:18E7415PXQ) 		Calendula officinalis Flowering Top6.25 [hp_X] in 125 mL
Hypericum perforatum(UNII: XK4IUX8MNB)
(Hypericum perforatum - UNII:XK4IUX8MNB) 		Hypericum perforatum6.25 [hp_X] in 125 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Polysorbate 20(UNII: 7T1F30V5YH)
Disodium Laureth Sulfosuccinate(UNII: D6DH1DTN7E)
Cocamidopropyl Betaine(UNII: 5OCF3O11KX)
Apricot(UNII: 269CJD5GZ9)
Chondrus(UNII: XR12Z4HLEA)
Phenoxyethanol(UNII: HIE492ZZ3T)
Benzyl Alcohol(UNII: LKG8494WBH)
Xanthan Gum(UNII: TTV12P4NEE)
Tea Tree Oil(UNII: VIF565UC2G)
Lavender Oil(UNII: ZBP1YXW0H8)
Grapefruit(UNII: O82C39RR8C)
Linalool, Dl-(UNII: D81QY6I88E)
Product Characteristics
Color YELLOW (includes texture from exfoliation ingredients) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57687-510-25125 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED HOMEOPATHIC 09/01/2010

PRINCIPAL DISPLAY PANEL

NDC # 057687-610-25

nelsons ®

pure
&clear™

apricot seed
exfoliating wash
acne care

naturally & gently deep cleans pores
dermatologically tested
fragrance free, paraben free

125ml (4.2 fl oz) e

natural care since 1860

step 1 Homeopathic

Principal Display Panel - 125 ml Tube Label