SOOLANTRA (Page 3 of 3)

Package Label — 30 g

soolantra_30g_carton_P52447-1
(click image for full-size original)

NDC 0299-3823-30

soolantra®

(ivermectin) cream, 1%

NET WT. 30 g

Rx only

For Topical Use Only

Keep Out of Reach of Children

GALDERMA

SOOLANTRA ivermectin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-3823
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
ISOPROPYL PALMITATE
METHYLPARABEN
OLEYL ALCOHOL
PHENOXYETHANOL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM HYDROXIDE
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-3823-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0299-3823-30)
2 NDC:0299-3823-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0299-3823-45)
3 NDC:0299-3823-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (0299-3823-60)
4 NDC:0299-3823-02 1 TUBE in 1 BLISTER PACK contains a TUBE
4 2 g in 1 TUBE This package is contained within the BLISTER PACK (0299-3823-02)
5 NDC:0299-3823-00 2 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206255 01/01/2015
Labeler — Galderma Laboratories, L.P. (047350186)
Registrant — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production, Inc. 251676961 manufacture (0299-3823)
Establishment
Name Address ID/FEI Operations
Ameripac, Inc 196515639 repack (0299-3823)

Revised: 11/2019 Galderma Laboratories, L.P.

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