Label: THERADERM- methyl salicylate 2-ethylbutyrate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 16903-169-02 - Packager: Manna Omni International Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated February 19, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Warning: For External Use Only.
Use only as directed. Avoid contact with eyes or mucus menmbranes. Do not apply to worn, damaged, or very sensitive skin. Test on a small area before use. Do not Use in combination with other external analgesic products. Do not bandage tightly, or cover with any type of wrap, except clothing. If condition worsens , or persists for more than 7 days, discontinue use and consult a physcian.
- Keep out of the reach of Children.
- INDICATIONS & USAGE
- Dosage:
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Other Ingredients:
Aloe Extract, am pelopsis radix extract, bletilla tuber extract, Carthmiflos extract,cimicifugae rhizome extract,echinopsis radix extract, glycerin, glycerrhizae radix extract,kaolin,methyl saliciate, myrrha extract, frankincense extract,Poly Acrylic acid,polysorbate 80,polyvinyl alcohol,propyl glycol,propyl paraben, purified water,rhei rhizome extract,titanium oxide,triethanolamine,glucosamine,and MSM.
- Active Ingredients:
- Purpose:
- Use:
- Theraderm Pain Relieving Spray
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INGREDIENTS AND APPEARANCE
THERADERM
methyl salicylate 2-ethylbutyrate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16903-169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT 12 mg in 120 mg METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G) METHYL SALICYLATE 2-ETHYLBUTYRATE 24 mg in 120 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 12 mg in 120 mg CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL 5 mg in 120 mg Inactive Ingredients Ingredient Name Strength PRUNUS PERSICA SEED (UNII: V9C81470RR) 2 mg in 120 mg (P-HYDROXYPHENYL)DIMETHYLSULFONIUM CHLORIDE (UNII: 33P1U651QS) 24 mg in 120 mg ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 1 mg in 120 mg LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97) 2 mg in 120 mg FRANKINCENSE OIL (UNII: 67ZYA5T02K) 2 mg in 120 mg MYRRH OIL (UNII: H74221J5J4) 2 mg in 120 mg GLYCERIN (UNII: PDC6A3C0OX) 7 mg in 120 mg COCONUT OIL (UNII: Q9L0O73W7L) 1 mg in 120 mg LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 3 mg in 120 mg LAVENDER OIL (UNII: ZBP1YXW0H8) 1 mg in 120 mg ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ) 2 mg in 120 mg ZINGIBER CASSUMUNAR ROOT (UNII: 3NG517NPD8) 2 mg in 120 mg Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16903-169-02 120 mg in 1 BOTTLE; Type 0: Not a Combination Product 03/17/2017 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/17/2017 Labeler - Manna Omni International Incorporated (019109468)
