THERADERM PAIN RELIEVING PATCH- methyl salicylate menthol eucalyptus patch

Theraderm Pain Relieving Patch by

Drug Labeling and Warnings

Theraderm Pain Relieving Patch by is a Otc medication manufactured, distributed, or labeled by Manna Omni International Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THERADERM PAIN RELIEVING PATCH 
methyl salicylate menthol eucalyptus patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16903-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	105
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	31.5
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	105

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)	105

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16903-168-01	5 in 1 PACKAGE; Type 0: Not a Combination Product	06/05/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/05/2014

Labeler - Manna Omni International Incorporated (019109468)

Registrant - Manna Omni International Incorporated (019109468)

Establishment
Name	Address	ID/FEI	Business Operations
Manna Omni International Incorporated		019109468	manufacture(16903-168)