STOP SPOT- salicylic acid gel 
Clearly Pte 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.

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Drug Facts

Active ingredient 

Salicylic Acid 2%

Purpose

Acne treatment

Uses

Clears acne blemishes and allows the skin to heal

Warnings

For External Use Only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Keep out of Reach of Children, if ingested, seek medical help or contact Poison
Control Center immediately

Directions

Other information

Store below 30°C (86° F)

Inactive ingredients

water, alcohol denat, glycerin, butylene glycol, propanediol, PEG-30 castor oil, dipotassium glycyrrhizate, phenoxyethanol, glycolic acid, sclerotium gum,xanthum gum, sodium hydroxide, farnesol, ethylhexylglycerin, sulfur

Product label

image descriptionimage description

STOP SPOT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72521-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPANEDIOL (UNII: 5965N8W85T)  
PEG-30 CASTOR OIL (UNII: GF873K38RZ)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FARNESOL (UNII: EB41QIU6JL)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SULFUR (UNII: 70FD1KFU70)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72521-001-011 in 1 CARTON07/01/2021
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2021
Labeler - Clearly Pte Ltd (659280734)
Establishment
NameAddressID/FEIBusiness Operations
CHAKS COSMETIC DESIGN & SERVICES PTE LTD595557596manufacture(72521-001)

Revised: 1/2023
Document Id: f2258c7d-4acd-2570-e053-2995a90a76f2
Set id: a0ede9a8-ff34-4c00-a6ca-f227d0df17a7
Version: 2
Effective Time: 20230113
 
Clearly Pte Ltd