SILKA ANTIFUNGAL- tolnaftate liquid 
Genomma Lab USA

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.

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Silka® Antifungal Liquid

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

  • Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.

Questions or comments?

Call toll free 1-877-994-3666

Monday to Friday, 8 am to 6 pm Central time.

Distributed by:
Genomma Lab., Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 13 ML Bottle Carton

SILKA®

MAX STRENGTH

ANTIFUNGAL
LIQUID

»
KILLS
FUNGUS
»
STOPS ITCHING
AND BURNING
»
HELPS RESTORE
SKIN HEALTH

BEFORE
AFTER
DRAMATIZATION

WITH BRUSH
APPLICATOR

CLINICALLY PROVEN
AGAINST ATHLETE'S
FOOT FUNGUS

0.45 FL OZ / 13 ML

PRINCIPAL DISPLAY PANEL - 13 ML Bottle Carton
SILKA ANTIFUNGAL 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
RICE BRAN OIL (UNII: LZO6K1506A)  
SESAME OIL (UNII: QX10HYY4QV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-083-011 in 1 CARTON03/22/2022
113 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/22/2022
Labeler - Genomma Lab USA (832323534)

Revised: 3/2022
Document Id: e90b344a-8558-4061-9fbe-2f89b219b97b
Set id: 550d2a9b-4b23-47e5-9dc6-df1fc39a0f21
Version: 2
Effective Time: 20220323
 
Genomma Lab USA