Oheal Ringworm Cream by Dr.luke Healthcare LLC 83176-009 Completed

Oheal Ringworm Cream by

Drug Labeling and Warnings

Oheal Ringworm Cream by is a Otc medication manufactured, distributed, or labeled by Dr.luke Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

83176-009 Completed

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

OHEAL RINGWORM CREAM 
ringworm cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALMOND OIL (UNII: 66YXD4DKO9)
CLOVE OIL (UNII: 578389D6D0)
MENTHOL (UNII: L7T10EIP3A)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83176-009-01	56 g in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/31/2023	11/21/2024

Labeler - Dr.luke Healthcare LLC (118868014)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.luke Healthcare LLC		118868014	label(83176-009) , manufacture(83176-009)

Revised: 11/2024

Document Id: 2764822b-1424-841b-e063-6294a90a231a

34390-5

Set id: fd0a1f0f-06aa-8cd7-e053-6394a90ab7b6

Version: 2

Effective Time: 20241120