TRIPLE X-LOTION- glycolic acid, sulfur, salicylic acid lotion 
EMS TRADE

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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80724-201

Active ingredient[s]

Glycolic Acid 3%

Sulfur 3%

Salicylic Acid 0.5%

Purpose

Acne treatment

Use[s]

The Serum to relive irritation of troubled skin, especially for sensitive skin type (Hypoallergenic test completed)

The Lotion to relive and eliminate sebum and dead keratin cells inside the pores, the root cause of acne skin. (Suitable for acne-prone skin type)

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

*Before use this product, please read the directions and warnings carefully

*The Lotion should be used at night time (The Serum is recommended to use in the morning and night time)

Inactive ingredients

Package Label

30ml NDC: 80724-201-01 Label

60ml NDC: 80724-201-02 Label

TRIPLE X-LOTION 
glycolic acid, sulfur, salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80724-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID3 g  in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
PANTHENOL (UNII: WV9CM0O67Z)  
NEPIDERMIN (UNII: TZK30RF92W)  
BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHAMOMILE (UNII: FGL3685T2X)  
STEARETH-2 (UNII: V56DFE46J5)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
STEARETH-21 (UNII: 53J3F32P58)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)  
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
SQUALANE (UNII: GW89575KF9)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80724-201-0130 mL in 1 TUBE; Type 0: Not a Combination Product10/15/2020
2NDC:80724-201-0260 mL in 1 TUBE; Type 0: Not a Combination Product10/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2020
Labeler - EMS TRADE (689944382)
Registrant - EMS TRADE (689944382)
Establishment
NameAddressID/FEIBusiness Operations
EMS TRADE689944382manufacture(80724-201)

Revised: 12/2023
Document Id: 0c4b2490-fc08-1eb0-e063-6294a90a57ed
Set id: b1aae991-7766-14aa-e053-2a95a90af462
Version: 2
Effective Time: 20231212
 
EMS TRADE