STOP SPOT- salicylic acid gel

STOP SPOT by

Drug Labeling and Warnings

STOP SPOT by is a Otc medication manufactured, distributed, or labeled by Clearly Pte Ltd, CHAKS COSMETIC DESIGN & SERVICES PTE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

KEEP OUT OF REACH OF CHILDREN

Directions

• Clean the skin thoroughly before applying this product
• cover the entire affected area/spot with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

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

INGREDIENTS AND APPEARANCE

STOP SPOT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72521-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72521-001-01	1 in 1 CARTON	07/01/2021
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2021

Labeler - Clearly Pte Ltd (659280734)

Establishment
Name	Address	ID/FEI	Business Operations
CHAKS COSMETIC DESIGN & SERVICES PTE LTD		595557596	manufacture(72521-001)