ANTIFUNGAL MEDICATED BODY WASH- tolnaftate gel

ANTIFUNGAL MEDICATED BODY WASH by

Drug Labeling and Warnings

ANTIFUNGAL MEDICATED BODY WASH by is a Otc medication manufactured, distributed, or labeled by Rida LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1.0%

Purpose

Antifungal

Uses

For treatment of most

• jock itch
• ringworm
• atheletes foot
• tinea versicolor

Relieves

• itching
• scaling
• burning
• redness
• cracking
• associated discomfort

WARNINGS

Warning

For external use only.

When using this product
When using this product avoid contact with the eye

Stop use and ask a doctor ifirritation occurs or if there is no
improvement within 2 weeks for jock itch or within 4 weeks for athlete's
foot and ringworm.

Do not use
Do Not use on children under 2 under 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.

KEEP OUT OF REACH OF CHILDREN

Directions

• Make sure to dry affected area thoroughly.
• Supervise children in the use of this product.
• For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
• Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
• This product is not effective on the scalp or nails.

Inactive ingredients

TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE

Product label

INGREDIENTS AND APPEARANCE

ANTIFUNGAL MEDICATED BODY WASH 
tolnaftate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83004-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
EUCALYPTUS OIL (UNII: 2R04ONI662)
WATER (UNII: 059QF0KO0R)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
GLYCERIN (UNII: PDC6A3C0OX)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83004-012-01	56 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/06/2024
2	NDC: 83004-012-02	113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/06/2024
3	NDC: 83004-012-03	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/06/2024
4	NDC: 83004-012-04	453 g in 1 PACKAGE; Type 0: Not a Combination Product	06/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/06/2024

Labeler - Rida LLC (004425803)