HONGO KILLER- tolnaftate cream
Efficient Laboratories Inc

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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Hongo Killer ®

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most:

athlete's foot (tinea pedis)
ringworm (tinea corporis)
effectively soothes are relieves:
itching
burning
cracking
helps prevent most athlete's foot with daily use

Warnings

For external use only.

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

For Diaper Rash

When using this product

When using this product avoid contact with eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks

Keep out of reach of children. If swallowed, get medical help or, contact a Poison Control Center right away: 800-222-1222.

Directions

clean the affected area and dry thoroughly
apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor
supervise children in the use of this product
for athlete's foot, pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists, consult a doctor
to prevent athlete's foot, wash the feet, and dry thoroughly. Apply a thin layer over the affected area twice daily (morning and/or night)
this product is not effective on scalp or nails

Other information

store at 15°to 30°C (59°to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions or comments?

Please call 305-805-3456
(M-F 9:00 am-5:00 pm EST www.efficientlabs.com

Distributed by Efficient Laboratories, Inc.,
Miami, FL 33166 USA

PRINCIPAL DISPLAY PANEL -

label label label

HONGO KILLER
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58593-286
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
CETETH-20 (UNII: I835H2IHHX)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58593-286-05	1 in 1 CARTON	01/01/2000
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58593-286-10	1 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2000
3	NDC:58593-286-01	1 in 1 CARTON	01/01/2000
3		28 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:58593-286-22	28 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	01/01/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	01/01/2000

Labeler - Efficient Laboratories Inc (969044932)

Registrant - Efficient Laboratories Inc (969044932)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex, LLC		062808196	manufacture(58593-286)

Revised: 12/2021

Document Id: d21a4a4a-5c2d-01d9-e053-2995a90ac2d8

Set id: 5a8bb110-2687-4e29-a771-2362d7726701

Version: 14

Effective Time: 20211201

Efficient Laboratories Inc