TRSTAY LUXE CLARIFYING ACNE REPAIR SERUM- salicylic acid gel

TRSTAY LUXE Clarifying Acne Repair Serum by

Drug Labeling and Warnings

TRSTAY LUXE Clarifying Acne Repair Serum by is a Otc medication manufactured, distributed, or labeled by Guangdong Meizhiyuan Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TRSTAY LUXE Clarifying Acne Repair Serum

ACTIVE INGREDIENT

Salicylic Acid 2%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

For the treatment of acne.
Helps clear up acne blemishes.
Helps prevent the developmentof new acne blemishes.

WARNINGS

For external use only.

WHEN USING

Avoid contact with eyes. lf contactoccurs, rinse thoroughly with water.
Skin irritation and dryness are morelikely to occur if you use anothertopical acne medication at the sametime. lf irritation occurs, only useone topical acne medication at atime.

STOP USE

Stop use and ask a doctor if:lrritation becomes severe.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help orcontact a Poison Control Centerright away.

DOSAGE & ADMINISTRATION

Clean the skin thoroughly beforeapplying this product.
Cover the entire affected area witha thin layer one to two times daily.
Because excessive drying of the skinmay occur, start with one applicationdaily, then gradually increase to twotimes daily if needed or as directedby a doctor.
If bothersome dryness or peelingoccurs, reduce application to oncea day or every other day.

STORAGE AND HANDLING

Store at room temperatureAvoid excessive heat.

INACTIVE INGREDIENT

Water
Propylene Glycol
Niacinamide
Guava Fruit Extract
Aloe Vera Extract
Portulaca Oleracea Extract
Tocopheryl Acetate
Aloe Vera Extract
Menthol
Sodium Hydroxide
Xanthan Gum
Dipotassium Glycyrrhizate
Azelaic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRSTAY LUXE CLARIFYING ACNE REPAIR SERUM 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85277-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PSIDIUM GUAJAVA FRUIT (UNII: 74O70D6VG0)
PURSLANE (UNII: M6S840WXG5)
AZELAIC ACID (UNII: F2VW3D43YT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NIACINAMIDE (UNII: 25X51I8RD4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85277-001-01	1 in 1 BOX	02/20/2025
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85277-001-02	1 in 1 BOX	02/20/2025
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 85277-001-03	1 in 1 BOX	02/20/2025
3		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 85277-001-04	1 in 1 BOX	02/20/2025
4		20 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 85277-001-05	1 in 1 BOX	02/20/2025
5		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 85277-001-06	1 in 1 BOX	02/20/2025
6		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/20/2025

Labeler - Guangdong Meizhiyuan Biotechnology Co., Ltd. (403967973)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Meizhiyuan Biotechnology Co., Ltd.		403967973	manufacture(85277-001)