AZELAIC ACID 20% CREAM cream

Azelaic Acid 20% Cream by

Drug Labeling and Warnings

Azelaic Acid 20% Cream by is a Otc medication manufactured, distributed, or labeled by Yiwu Luoxin E Commerce Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPONENTS

Salicylic acid 2%

PURPOSE

wart remover

INDICATIONS & USAGE

Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed

WARNINGS

Forevemaluseony Avoid coniac wth eves li coniac ocus nse ihorouthly wt waier Keep out ofreach oi chidrenifvou ale preanant.nursing. otiaveanyunderving medca condion.consutyou healthcare provider before using the product

DOSAGE & ADMINISTRATION

For external use only.

DO NOT USE

Discontinue use if any irritation or adverse reaction occurs

WHEN USING

When using this product, avoid contact with eyes. lf contact occurs, rinse thoroughly with waterDiscontinue use if any irritation or adverse reaction occurs.

STOP USE

on broken or irritated scalp

KEEP OUT OF REACH OF CHILDREN

If sxralowed, get medical help or contact a Poison Conirol Cenler ngiht away.

INACTIVE INGREDIENT

Acrylates copolymer, Ethyl acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AZELAIC ACID 20% CREAM 
azelaic acid 20% cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84756-599
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
SESAME OIL (UNII: QX10HYY4QV)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84756-599-01	5 g in 1 BOX; Type 0: Not a Combination Product	12/11/2024
2	NDC: 84756-599-02	15 g in 1 BOX; Type 0: Not a Combination Product	12/11/2024
3	NDC: 84756-599-03	30 g in 1 BOX; Type 0: Not a Combination Product	12/11/2024
4	NDC: 84756-599-04	50 g in 1 BOX; Type 0: Not a Combination Product	12/11/2024
5	NDC: 84756-599-05	100 g in 1 BOX; Type 0: Not a Combination Product	12/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/11/2024

Labeler - Yiwu Luoxin E Commerce Co Ltd (698835114)

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu Luoxin E Commerce Co Ltd		698835114	manufacture(84756-599)