Label: THERA DERM ROLL ON- methyl salicylate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 16903-171-04 - 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
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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Warning: For External Use Only
Use only as directed. Avoid contact with the eyes and mucous membranes. Do not apply to wounds, damaged or very sensitive skin. Test on a small area before use. DO not use in combination with other analgesic products.DO not bandage tightly or cover with any type of wrap except clothing. If condition worsens, or persists for more than seven days, discontinue use and consult a physician.
- Keep out of the Reach of Children
- Active Ingredients:
- Inactive Ingredients:
- PURPOSE
- Theraderm Roll on
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INGREDIENTS AND APPEARANCE
THERA DERM ROLL ON
methyl salicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16903-171 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G) METHYL SALICYLATE 2-ETHYLBUTYRATE 18 mg in 90 mg CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 4 mg in 90 mg PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 9 mg in 90 mg MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- (UNII: 2WL8FX4EEZ) (MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- - UNII:2WL8FX4EEZ) MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- 9 mg in 90 mg Inactive Ingredients Ingredient Name Strength PRUNUS PERSICA FLOWER BUD (UNII: 8S5Y7XFT0F) 2 mg in 90 mg NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK) 2 mg in 90 mg ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ) 2 mg in 90 mg ZINGIBER CASSUMUNAR ROOT OIL (UNII: O47HX41O6C) 2 mg in 90 mg MYRRH (UNII: JC71GJ1F3L) 2 mg in 90 mg ALOE (UNII: V5VD430YW9) 2 mg in 90 mg SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN) 2 mg in 90 mg CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5) 2 mg in 90 mg LAVENDER OIL (UNII: ZBP1YXW0H8) 1 mg in 90 mg ANGELICA SINENSIS ROOT (UNII: B66F4574UG) 2 mg in 90 mg LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97) 2 mg in 90 mg FRANKINCENSE OIL (UNII: 67ZYA5T02K) 2 mg in 90 mg STEARIC ACID (UNII: 4ELV7Z65AP) 5 mg in 90 mg PHENOXYETHANOL (UNII: HIE492ZZ3T) 1 mg in 90 mg COCONUT OIL (UNII: Q9L0O73W7L) 2 mg in 90 mg Product Characteristics Color white (Smooth Non -greasy Roll On) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16903-171-04 90 mg in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/31/2017 Labeler - Manna Omni International Incorporated (019109468)
is to be used on sore muscles, for minor aches and pains. If pain persists for more than three days consult your doctor.Apply small amount onto affected area and repeat three (3) to four (4) times daily.
