Label: THERADERM PAIN RELIEVING PATCH- methyl salicylate menthol eucalyptus patch
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Contains inactivated NDC Code(s)
NDC Code(s): 16903-168-01 - Packager: Manna Omni International Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 9, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts: Active Ingredients
- Uses:
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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
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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
- Indications and Usage:
- Thera Derm Pain Relieving Patch
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INGREDIENTS AND APPEARANCE
THERADERM PAIN RELIEVING PATCH
methyl salicylate menthol eucalyptus patchProduct 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)
