THERADERM PAIN RELIEVING PATCH- methyl salicylate menthol eucalyptus patch 
Manna Omni International Incorporated
Reference Label Set Id: 5d925706-e8ed-46fd-e053-2991aa0a2f89

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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TheraDerm Pain Relieving Patch

Drug Facts: Active Ingredients

Menthol

Methal Salicylate

Eucalyptus Oil

Uses:

Temporarily relieves minor aches and pains of muscles and joints due to simple back ache, arthritis, strains, and sprains.

Warnings: For External Use Only

Use as directed

do not get into eyes or on mucous membranes

do not apply to wounds, damaged. or sensative skin

do not bangage tightly or cover with any type of wrap or cloth

do not use with a heating pad or apply external heat

do not use in combination with other external analgesic products

Stop use and ask a doctor if:

Condition worsens

excessive redness, burning,irritation, or discomfort of the skin developes

pain persists for more than seven days

symptoms clear up and occur again within a few days

Keep out of the Reach of Children

If swallowed, get medical help and contact a poision center right away.

Directions:

Adults and children 12 years and over apply to affected area, change patch 2 to 3 times daily.

Children under 12 years ask a doctor before use.

How to apply:

Clean and dry affected area.

Cut open poutch and remove patch.

If desired, cut patch to size.

remove protective film from adhesive, apply directly onto site of pain, and secure ith adhesive strips.

Inactive Ingredients

Aloe extract, Zinc Oxide, Angelicae Sinensis RX, Cauda, Salviae Militorrhiza. CHuanxiong, Paeonea Rubra, Frankinsence, Myrrha, Notoginseng, Carthami Flos Persicae Sm, Angelica Pubescentis RX, Zingiberis RZ, Thymol.

Indications and Usage:

Thera Derm Pain relieving Patch is used for minor back aches, muscle aches, sprains, and strains.

Thera Derm Pain Relieving Patch

Thera Derm Patch

THERADERM PAIN RELIEVING PATCH 
methyl salicylate menthol eucalyptus patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16903-168
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL105 
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE31.5 
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL105 
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9) 105 
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16903-168-015 in 1 PACKAGE; Type 0: Not a Combination Product06/05/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/05/2014
Labeler - Manna Omni International Incorporated (019109468)
Registrant - Manna Omni International Incorporated (019109468)
Establishment
NameAddressID/FEIBusiness Operations
Manna Omni International Incorporated019109468manufacture(16903-168)

Revised: 11/2017
Document Id: 5d9546ec-9b83-69a6-e053-2a91aa0a4e47
Set id: e0e280f4-2c12-4203-be54-c19821b13393
Version: 2
Effective Time: 20171109
 
Manna Omni International Incorporated