FASTRIN ANTI - FUNGAL SKIN CARE- clotrimazole ointment 
Aidance Skincare & Topical Solutions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Cures most fungal skin infections, including ringworm and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Warnings

For external use only. Do not use on children under two years of age unless directed by a physician. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.

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 twice daily (morning and night) or as directed by a doctor.

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

Anti - Fungal

Skin Care Ointment

Net WT 50g (1.76 oz.)

Tube Label

FASTRIN ANTI - FUNGAL SKIN CARE 
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1.0 g  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:24909-601-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
2NDC:24909-601-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/2017
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-601) , label(24909-601)

Revised: 6/2017
Document Id: 6753533a-2405-444f-9bfa-e10eb5ee47e5
Set id: 40498493-2176-4ab5-8966-8119a44d3293
Version: 1
Effective Time: 20170601
 
Aidance Skincare & Topical Solutions, LLC