SIMPLY VITAL ANTIFUNGAL CREAM- clotrimazole cream

SIMPLY VITAL Antifungal Cream by

Drug Labeling and Warnings

SIMPLY VITAL Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by ALPHA PLANTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Clotrimazole 1.00%

Purpose

Antifungal

Uses:

• proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
• for effective relief of itching, scaling, burning, soreness, irritation and discomfort.

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

• irritation occurs.
• condition persists.
• there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Discontinue use and ask a doctor if

Keep out of reach of children.

get medical help or contact a Poison Control Center right away. If swallowed,

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

• clean the affected area and dry thoroughly.
• apply a thin layer of the product 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; weat 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 longer, consult a doctor.
• this product is not effective on the scalp or nails. 

Other information:

• protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Questions?

+1 (205) 624-9177

Package Labeling:

INGREDIENTS AND APPEARANCE

SIMPLY VITAL ANTIFUNGAL CREAM 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82460-344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL STEARATE (UNII: 06RI5UQA7L)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
TEA TREE OIL (UNII: VIF565UC2G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
THYME (UNII: CW657OBU4N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82460-344-00	60 mL in 1 JAR; Type 0: Not a Combination Product	07/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	07/25/2022

Labeler - ALPHA PLANTS INC (118246522)