OHEAL SHINGLES PAIN RELIEF CREAM- shingles pain relief 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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83176-004
OHEAL SHINGLES PAIN RELIEF CREAM

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

83176-004-01

OHEAL SHINGLES PAIN RELIEF CREAM 
shingles pain relief cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316)  
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)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83176-004-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/10/2023
Labeler - Dr.luke Healthcare LLC (118868014)
Establishment
NameAddressID/FEIBusiness Operations
Dr.luke Healthcare LLC118868014manufacture(83176-004)

Revised: 3/2023
Document Id: f684c4e3-f61a-b5f1-e053-2a95a90a1e9e
Set id: f684c4e3-f619-b5f1-e053-2a95a90a1e9e
Version: 1
Effective Time: 20230309
 
Dr.luke Healthcare LLC