OHEAL SHINGLES PAIN RELIEF Cream by Dr.luke Healthcare LLC 83176-004 Completed

OHEAL SHINGLES PAIN RELIEF Cream by

Drug Labeling and Warnings

OHEAL SHINGLES PAIN RELIEF 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 SHINGLES PAIN RELIEF CREAM- shingles pain relief cream cream 
Dr.luke Healthcare LLC

----------

83176-004 Completed

Active Ingredient

MENTHOL, UNSPECIFIED FORM 3%

Purpose

Topical analgesic

Use

For the treatment of symptomsof shingles, hives, and rashes.

Warnings

For external use only.Avoid contact with eyes, flush with water immediately if it getsinto your eyes.Keep out of reach of children.

Do not use

On broken skin
On eyes area

WHEN USING SECTION

For external use only.Avoid contact with eyes, flush with water immediately if it getsinto your eyes.Keep out of reach of children.

STOP USE section

If you are allergic to this product.

Directions

Apply to the affected areas 2-3 times daily.
Children should use it under the supervision of adults.

Inactive ingredients

Water, Mineral oil, Glycerin, Cetyl Alcohol, Aloevera Extract,Coconut Oil, Propylene Glycol, Artemisia Extract, K chiaSoparia seeds , Dictamni Cortex, Smilax Glabra Roxb.Solidago decurrens, Phellodendron amurense Ruprecht.Euphorbia Fischeriana Root,Gleditsia Sinensis, StemonaTuberosa,Equally extracted herbalextracts,Sophora flavescensVitamin E.

QUESTIONS

www.ohealpro.com
Info@ohealpro.com

Keep out of reach of children.

83176-004-01

OHEAL SHINGLES PAIN RELIEF CREAM 
shingles pain relief cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE (UNII: V5VD430YW9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EUPHORBIA FISCHERIANA ROOT (UNII: R4DRG4762Y)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
GLYCERIN (UNII: PDC6A3C0OX)
ARTEMISIA PRINCEPS WHOLE (UNII: 2849G48V9J)
COCONUT OIL (UNII: Q9L0O73W7L)
SOLIDAGO DECURRENS WHOLE (UNII: Y026RJV99T)
CETYL ALCOHOL (UNII: 936JST6JCN)
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)
SMILAX LANCEIFOLIA WHOLE (UNII: WBP9EYZ1XE)
PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L)
GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83176-004-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/10/2023	11/21/2024

Labeler - Dr.luke Healthcare LLC (118868014)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.luke Healthcare LLC		118868014	manufacture(83176-004)

Revised: 11/2024

Document Id: 27648245-e5d0-b1a0-e063-6294a90a4962

34390-5

Set id: f684c4e3-f619-b5f1-e053-2a95a90a1e9e

Version: 2

Effective Time: 20241120