FASTRIN INCONTINENCE AND OSTOMY RASH CARE- calendula, comfrey, thuja occidentalis ointment 
Aidance Skincare & Topical Solutions, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts

Active Ingredient

Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

Purpose

Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief

Uses

Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.

Warnings

For external use only. Do not get into eyes.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.

Inactive Ingredients

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

PRINCIPAL DISPLAY PANEL - 50g Tube

Fastrin

Incontinence & Ostomy

Rash Care Ointment

Net WT 50g (1.76 oz.)

Tube Label

FASTRIN INCONTINENCE AND OSTOMY RASH CARE 
calendula, comfrey, thuja occidentalis ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
COMFREY (UNII: D05HXK6R3G) (COMFREY - UNII:D05HXK6R3G) COMFREY1 [hp_X]  in 100 g
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE3 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
HONEY (UNII: Y9H1V576FH)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
TEA TREE OIL (UNII: VIF565UC2G)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-603-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
2NDC:24909-603-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2017
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-603) , label(24909-603)

Revised: 6/2017
Document Id: 47fa88a4-4774-4a84-a647-05bbde954fff
Set id: 3af07373-2bbc-4428-bb63-4313dc1dd8b5
Version: 1
Effective Time: 20170601
 
Aidance Skincare & Topical Solutions, LLC