TERRASIL SKIN REPAIR- allantoin ointment 
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions

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Drug Facts

Active Ingredient                                 

Allantoin 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes, and burns. Helps prevent, temporarily protect, and relieve chapped or cracked skin.

Warnings

For external use only. When using this product, do not get into eyes. Stop use and ask a doctor ifcondition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Do not useon deep or puncture wounds, animal bites or serious burns. K eep out of reach of children.If swallowed, call Poison Control or seek medical help.

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Bandage when appropriate. Repeat procedure 1 to 3 times daily until skin improvement or as directed by a doctor.

Inactive Ingredients

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

Other information

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

Product label

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TERRASIL SKIN REPAIR 
allantoin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TEA TREE OIL (UNII: VIF565UC2G)  
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-032-1414 g in 1 TUBE; Type 0: Not a Combination Product05/15/2024
2NDC:24909-032-5050 g in 1 TUBE; Type 0: Not a Combination Product05/15/2024
3NDC:24909-032-20200 g in 1 JAR; Type 0: Not a Combination Product05/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/15/2024
Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-032)

Revised: 5/2024
Document Id: 192735bd-12a3-4fe9-e063-6294a90ace1a
Set id: 92a23c7f-6b89-49cb-93e2-49ab7a85c86d
Version: 2
Effective Time: 20240523
 
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions