Label: STOPAIN MIGRAINE PAIN RELIEVING- mentholum, belladonna, iris versicolor, sanguinaria canadensis gel
- NDC Code(s): 63936-8700-1, 63936-8700-2
- Packager: TROY MANUFACTURING, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 25, 2023
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
Ask a doctor before use iif you have
never had migraines diadnosed by a health professional
- Do not apply to broken or irritated skin
- Do not apply to forehead or temples
- For external use only. This product should not be used topically on children younger than 2 years of age, nor should it be applied on any mucus membranes of any age child or adult. Seek the advice of your Healthcare professional before using this product topically on children 2 to 12 years of age.
- Avoid contact with eyes. If gel gets into eyes or mucus membranes flush with cool water for 1-2 minutes.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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Directions
Adults and children over 12 years:
- Remove cap
- For first application press down several times to prime actuator pump for use
- After actuator has been primed press and release pump once to dispense gel onto finger tips
- Apply to one side on back of neck and behind the ear, repeat for the other side, applying a single pump of product for each side
- For best results, apply as soon as you feel discomfort
- If after 30 minutes the symptoms still persist, reapply as needed, up to 4 times daily.
- Inactive Ingredients
- Other Information
- Package Labeling:
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INGREDIENTS AND APPEARANCE
STOPAIN MIGRAINE PAIN RELIEVING
mentholum, belladonna, iris versicolor, sanguinaria canadensis gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63936-8700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 [hp_X] in 50 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_X] in 50 mL IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 6 [hp_X] in 50 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 6 [hp_X] in 50 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PENTYLENE GLYCOL (UNII: 50C1307PZG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63936-8700-1 1 in 1 CARTON 03/20/2015 1 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:63936-8700-2 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/20/2015 Labeler - TROY MANUFACTURING, INC (160075248) Registrant - TROY MANUFACTURING, INC (160075248) Establishment Name Address ID/FEI Business Operations TROY MANUFACTURING, INC 160075248 manufacture(63936-8700)
