Oheal Manuka Honey Eczema Cream by Dr.luke Healthcare LLC

Drug Details [pdf]

OHEAL MANUKA HONEY ECZEMA CREAM- manuka honey eczema 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

Antifungal

Use

For Dermatitis, Psoriasis, Eczema, Rosacea, Shingles, Oily, Dry or Cracked Skin, General Skin Irritation, and more.

Warnings

1. For external use only.
2. Stop using it and ask the doctor if you are allergic to this product.
3. Avoid contact with eyes, flush with water immediately if it gets into eyes.
4. If you are pregnant or breastfeeding, please don’t use it.
5. Keep out of reach of children.
6. Do not ingest.
7. Do not use if safety seal is broken or missing. Wash hands after use.

Do not use

If you are pregnant, breastfeeding
On children under 10 years
On unhealed wounds after surgery
If you are allergic to this product

Stop Use

You are experiencing severe allergic reactions, local ulcers, heavy rash, edema, or severe pain.

Ask Doctor

If you are allergic, feel unwell, please seek medical advice

Keep Oot Of Reach Of Children

Please do not allow unconscious persons to come into contact with.

Directions

1.Before using this product, wash and dry the affected area with warm water.
2.Apply an appropriate amount, and knead gently for two minutes to absorb it to achieve better results fully 2-3 times a day.
3.Use it for 3-5 days after symptoms disappear to prevent recurrence.

Other information

If swallowed, rinse immediately with water, and get medical help or contact a poison control center right away.

Inactive ingredients

Rhinaca nthus Nasutus, HerbaViolae,
EeuphorbiaHir tall, Murrayaexotica L.,
Manthill1, Dryobala NopsSpp,
Sophora Flavescens, Manuka Honey,
CnidiumMonniericuss, ILAtin Title,
CortexDictamnil, Mosiacavaerieilev1,
RhizomaSmi Lacis alabrael, Phel,
lodendrn Amurenserupr1,
IFischereuphobiaR oot,
IGleditsiasinenesislinn1,
StemonaTuberosaLour.

Questions

www.ohealpro.com

Info@ohealpro.com

PACKAGE LABEL.

OHEAL MANUKA HONEY ECZEMA CREAM
manuka honey eczema cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-010
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
MINT (UNII: FV98Z8GITP)
LEPTOSPERMUM SCOPARIUM TOP (UNII: A5611M841M)
SMILAX GLABRA TUBER (UNII: PES3YXA3LR)
STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)
STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)
MURRAYA PANICULATA WHOLE (UNII: Y8ZAA3Z7WU)
VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54)
EUPHORBIA HIRTA (UNII: L13YF113GN)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BASSIA SCOPARIA WHOLE (UNII: 240G38P85Z)
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)
CIRSIUM JAPONICUM ROOT (UNII: JQN9IR918W)
CNIDIUM MONNIERI FRUIT OIL (UNII: JK0MS9P8YL)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
RHINACANTHUS NASUTUS WHOLE (UNII: QW70YFP724)
BORNEOL (UNII: M89NIB437X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 83176-010-01	96 g in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M005	06/10/2023	06/26/2023

Labeler - Dr.luke Healthcare LLC (118868014)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.luke Healthcare LLC		118868014	label(83176-010) , manufacture(83176-010)

Revised: 6/2023

Document Id: ff140a57-8ea8-d7a4-e053-6394a90a3c5e

Set id: fddb667f-f091-3f54-e053-6394a90ab304

Version: 2

Effective Time: 20230626