OTC Medication Information: Hi Vetic

HI VETIC- tolnaftate ointment
Sato Pharmaceutical Co., Ltd.

Active ingredient Tolnaftate 1%

Purpose Antifungal

Uses ■for effective treatment of most athlete’s foot, jock itch, and ringworm
■prevents the recurrence of 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

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, and within 2 weeks for jock itch

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

Directions
■for the treatment of athlete’s foot, jock itch, and ringworm
■cleanse the affected area with soap and water and dry throughly
■apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
■to prevent athlete’s foot
■cleanse the feet with soap and water and dry throughly
■apply a thin layer of the product to the feet once or twice daily (morning and/or night)
■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 ■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 longer, consult a doctor ■this product is not effective on the scalp or nails

Inactive ingredients Carboxymethylcellulose sodium, diethyl sebacate, fragrance, glyceryl monostearate, lauromacrogol 400, light mineral oil, polyoxyethylene cetylether, potassium stearate, propylene glycol, simethicone, sodium lauryl sulfate, stearyl alcohol, urea, water, white wax, zinc oxide.

hiveticointcart.jpg

Carton
(click image for full-size original)

HI VETIC
tolnaftate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-056
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
DIETHYL SEBACATE
POTASSIUM STEARATE
CETETH-20
SODIUM LAURYL SULFATE
GLYCERYL MONOSTEARATE
UREA
DIMETHICONE
ZINC OXIDE
WHITE WAX
STEARYL ALCOHOL
POLIDOCANOL
LIGHT MINERAL OIL
PROPYLENE GLYCOL
WATER
SILICON
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49873-056-01 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (49873-056-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M005 10/25/1996
Labeler — Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
Name Address ID/FEI Operations
Sato Pharmaceutical Co., Ltd. 715699133 manufacture (49873-056), label (49873-056), pack (49873-056)

Revised: 12/2023 Sato Pharmaceutical Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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