OHEAL RINGWORM CREAM- ringworm cream cream 
Dr.luke Healthcare LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Clotrimazole 1%

Purpose

Treat Skin Infections

Use

Ringworm related such as tinea corporis, kerion, skin irritation, fungal infection, itching & inflammation, tinea capitis

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 eyes

Do not use

Do not use

On broken skin
On eyes area
With any other drug

Stop Use

lf you are allergic to this product.lf symptoms persist for over 7 days or worsen, consult your physician.lf you are pregnant or breast-feedingYou become pregnant or are planning to become pregnant while using this product

Keep Oot Of Reach Of Children

Store this product in a suitable place.

Directions

1.Wash the affected area and dry thoroughly
2.Apply a thin layer over the affected area twice daily(morning and night), or as directed by a doctor.

Inactive ingredients

Water, Herba Violae, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Oleth-10 Phosphate, Triethanolamine, Polysorbate 20, Acrylates Copolymer, Cnidium Monniericuss, CortexDictamnil, Glycerin, Propylene Glycol, Uva Ursi (Bearberry) Extract, Beta-Glucan, Propolis Extract, Aloe Barbadensis Juice, Vitamin E, Camphor, Menthol, Tea Tree Oil, Lavender Oil, Jasmine Oil, Clove Flower Oil, Theobroma Cacao Cocoa Seed Butter, Rose Hip Flower Oil, Cetyl Hydroxyethylcellulose, Phenoxyethanol,Ethylhexylglycerin,Mint

Questions

www.ohealpro.com

Info@ohealpro.com

PRINCIPAL DISPLAY PANEL

001

OHEAL RINGWORM CREAM 
ringworm cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)  
WATER (UNII: 059QF0KO0R)  
OLETH-10 PHOSPHATE (UNII: Q95361F4VS)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
TEA TREE OIL (UNII: VIF565UC2G)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
COCOA BUTTER (UNII: 512OYT1CRR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MINT (UNII: FV98Z8GITP)  
VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54)  
CNIDIUM MONNIERI FRUIT OIL (UNII: JK0MS9P8YL)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
ALMOND OIL (UNII: 66YXD4DKO9)  
CLOVE OIL (UNII: 578389D6D0)  
MENTHOL (UNII: L7T10EIP3A)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83176-009-0156 g in 1 BOTTLE; Type 0: Not a Combination Product05/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00505/31/2023
Labeler - Dr.luke Healthcare LLC (118868014)
Establishment
NameAddressID/FEIBusiness Operations
Dr.luke Healthcare LLC118868014label(83176-009) , manufacture(83176-009)

Revised: 5/2023
Document Id: fd0a1f0f-06ab-8cd7-e053-6394a90ab7b6
Set id: fd0a1f0f-06aa-8cd7-e053-6394a90ab7b6
Version: 1
Effective Time: 20230531
 
Dr.luke Healthcare LLC