TERRASIL FIRST AID ANTISEPTIC WOUND AND BURN CARE KIT- hexylresorcinol kit

terrasil First Aid Antiseptic Wound and Burn Care Kit by

Drug Labeling and Warnings

terrasil First Aid Antiseptic Wound and Burn Care Kit by is a Otc medication manufactured, distributed, or labeled by Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                                  Purpose

Hexylresorcinol 0.10%                         First Aid Antiseptic

PURPOSE

Uses

First Aid to help protect against infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do not usein the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if the condition persists or gets worse. Do not uselonger than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, consult a physician.

KEEP OUT OF REACH OF CHILDREN

Directions

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, zinc oxide

Other information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Product label

INGREDIENTS AND APPEARANCE

TERRASIL FIRST AID ANTISEPTIC WOUND AND BURN CARE KIT 
hexylresorcinol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-040

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-040-01	1 in 1 KIT	10/02/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 g
Part 2		1

Part 1 of 2

TERRASIL FIRST AID ANTISEPTIC WOUND AND BURN CARE 
hexylresorcinol ointment

Product Information
Item Code (Source)	NDC: 24909-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N)	HEXYLRESORCINOL	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PALM OIL (UNII: 5QUO05548Z)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER STEARATE (UNII: 4H6PCL92ZN)
TEA TREE OIL (UNII: VIF565UC2G)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-041-14	14 g 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 Drug	M003

Part 2 of 2

TERRASIL HOSPITAL GRADE BANDAGING 
strip, adhesive, closure, skin

Product Information

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Exempt device	ABC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/02/2023

Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(24909-040, 24909-041)