AROMA A1 SKIN- salicylic acid lotion
GOWOONSESANG COSMETICS CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid 0.50%

INACTIVE INGREDIENT

Inactive ingredients:
ALCOHOL, WATER, MELALEUCA ALTERNIFOLIA(TEA TREE) LEAF OIL, TRICLOSAN, SODIUM CITRATE, BENZOPHENONE-3, CI 42090, CI 19140

PURPOSE

Purpose: Acne Treatment

WARNINGS

Warnings:
For external use only.
When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.
Do not use on wounds.
Stop and ask a doctor if you are allergic to any ingredients of this product.
Keep away from children. If swallowed get medical help immediately.

KEEP OUT OF REACH OF CHILDREN

Keep away from children. If swallowed get medical help immediately.

INDICATIONS AND USAGE

Indication and usage:
Wet cotton swab or pad with small amount. Apply only on the troubled spot and tap for penetration.
The product can cause irritation on sensitive skin when excess amount is used.

DOSAGE AND ADMINISTRATION

Dosage and administration: Take an appropriate amount according to your skin condition.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

AROMA A1 SKIN
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51621-045
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.75 mg in 150 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
TRICLOSAN (UNII: 4NM5039Y5X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51621-045-01	150 mL in 1 CARTON; Type 0: Not a Combination Product	10/01/2012	01/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/01/2012	01/10/2018

Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)

Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)

Name	Address	ID/FEI	Business Operations
Establishment
Biocostec Co., Ltd.		690407325	manufacture(51621-045)

Revised: 1/2018

Document Id: e2101bba-1b6c-4d22-a582-5c9fa79fbccf

Set id: 8455bf2e-32ef-4c68-b07f-350f7d1bb555

Version: 2

Effective Time: 20180110

GOWOONSESANG COSMETICS CO., LTD.