STOPAIN MIGRAINE PAIN RELIEVING- mentholum, belladonna, iris versicolor, sanguinaria canadensis gel 
TROY MANUFACTURING, INC

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.

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Stopain Migraine Topical Pain Relieving Gel

Drug Facts

Active Ingredients

Mentholum 1X HPUS-50.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Purpose

Migraine Pain

Uses

Temporarily relieves head pain associated with migraine.

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.

Stop use and consult a doctor if

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • excessive irritation of the skin occurs.

If pregnant or breast-feeding,

ask a health professional before use.

Directions

Adults and children over 12 years:

Inactive Ingredients

Carbopol polymer, ethanol (USP), pentylene glycol, silicone dioxide, triethanolamine, water (USP)

Other Information

Store at room temperature.

Package Labeling:

Label4

STOPAIN MIGRAINE PAIN RELIEVING 
mentholum, belladonna, iris versicolor, sanguinaria canadensis gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63936-8700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 [hp_X]  in 50 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 50 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 50 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63936-8700-11 in 1 CARTON03/20/2015
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:63936-8700-250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/20/2015
Labeler - TROY MANUFACTURING, INC (160075248)
Registrant - TROY MANUFACTURING, INC (160075248)
Establishment
NameAddressID/FEIBusiness Operations
TROY MANUFACTURING, INC160075248manufacture(63936-8700)

Revised: 1/2023
Document Id: f318d14a-9f86-4238-e053-2995a90abc15
Set id: 5641c17f-bf3f-48a5-a3a8-c80d381c17a4
Version: 5
Effective Time: 20230125
 
TROY MANUFACTURING, INC