FIRST AID ANTIFUNGAL MEDICATED- tolnaftate cream

First Aid Antifungal Medicated by

Drug Labeling and Warnings

First Aid Antifungal Medicated by is a Otc medication manufactured, distributed, or labeled by Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• proven effective in the prevention of athlete's foot with daily use
• for effective relief of itching, burning and cracking

Warnings

For external use only

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

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

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

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toes, wear well fitting shoes and change socks at least once daily
• use daily for 4 weeks, if condition persists longer, ask a doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalps or nails

Other information

• store between 20 to 25°C (68 to 77°F)
• Lot No & Expiration Date: See box or see crimp

Inactive ingredients

petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene,  propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.

SPL UNCLASSIFIED SECTION

Distributed by:

First Aid Research Corp.

Jupiter, Florida, USA 33478

Made in India

PRINCIPAL DISPLAY PANEL

First Aid Antifungal Medicated Cream
NET WT  1 OZ (28 g)

INGREDIENTS AND APPEARANCE

FIRST AID ANTIFUNGAL MEDICATED 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47046-164
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	white (White to Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47046-164-02	1 in 1 CARTON	01/02/2018
1	NDC: 47046-164-01	28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/02/2018

Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(47046-164)