CAREALL TOLNAFTATE- tolnaftate cream

CAREALL Tolnaftate by

Drug Labeling and Warnings

CAREALL Tolnaftate by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

KEEP OUT OF REACH OF CHILDREN

If Swallowed, get medical help or contact a Poison Control center right away.

INDICATIONS & USAGE

• Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• Proven effective in the prevention of athlete's foot
• Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet
  

WARNINGS

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if irritation occurs or 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

DOSAGE & ADMINISTRATION

•  Wash affected area and dry thoroughly
• Apply a thin layer over 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 shows 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 longer consult a doctor
• This product is not effective on scalp or nails

INACTIVE INGREDIENT

Propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-001
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
Propylene Glycol (UNII: 6DC9Q167V3)
Mineral Oil (UNII: T5L8T28FGP)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Alcohol (UNII: 936JST6JCN)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Ceteth-20 (UNII: I835H2IHHX)
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-001-05	14 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012
2	NDC: 51824-001-01	28 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/01/2012

Labeler - New World Imports, Inc (075372276)