TERASIC by Singular Dreamer dba True Marker

Drug Details [pdf]

TERASIC- salicylic acid gel
Singular Dreamer dba True Marker

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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Active Ingredient

salicylic acid 6%

Uses

For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with
psoriasis or thickened skin of palms and soles, corns and calluses.

Warnings

For external use only. Avoid contact with eyes an other mucous membranes. May cause mild irritation. If excessive irritation or sensitivity occurs, discontinue use and consult with your physician.

Do not use on children under 2 years of age. Read package insert carefully.

Flammable. Keep away from heat and open flame. Keep this and all medications out of reach of children.

Directions

Apply TERASIC GEL thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated (soaked in water) for at lest five minutes prior to application. The medication is washed off in the morning. In those areas where occlusion is difficult or impossible, application is washed off in the morning. In those areas where occlusion is difficult or impossible, application may be made more frequently. Once clearing is apparent, the occasional use of TERASIC GEL will usually maintain the remission. Unless hands are being treated, hands should be rinsed thoroughly after application.

Other Information

Store at controlled room temperature 59 to 86 F (15 to 30 C)

Inactive Ingredients

hydroxypropyl cellulose, propylene glycol

Questions or comments? call 888-811-2634

Product label

image description

TERASIC
salicylic acid gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83035-3200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 83035-3200-6	60 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2023	12/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/11/2023	12/15/2023

Labeler - Singular Dreamer dba True Marker (129504103)

Registrant - Singular Dreamer dba True Marker (129504103)

Revised: 11/2023

Document Id: 0a44a848-e90e-f914-e063-6394a90ae727

Set id: 662300cf-0468-458b-a758-2097b2dc63c4

Version: 4

Effective Time: 20231116

Trademark Results [TERASIC]

Mark Image Registration \| Serial	Company Trademark Application Date
TERASIC 78824538 3193557 Dead/Cancelled	Terasic Technologies Inc. 2006-02-27