SIMPLY VITAL ANTIFUNGAL CREAM- clotrimazole cream 
ALPHA PLANTS INC

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SIMPLY VITAL Antifungal Cream

Drug Facts

Active ingredient

Clotrimazole 1.00%

Purpose

Antifungal

Uses:

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:

Other information:

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:

Label2

SIMPLY VITAL ANTIFUNGAL CREAM 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82460-344
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82460-344-0060 mL in 1 JAR; Type 0: Not a Combination Product07/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00507/25/2022
Labeler - ALPHA PLANTS INC (118246522)

Revised: 11/2023
Document Id: 09e32c60-2b51-0226-e063-6294a90a6a2f
Set id: d3842de3-0d13-4dc2-920b-90a4b822bbb8
Version: 2
Effective Time: 20231111
 
ALPHA PLANTS INC