SITEROL- lidocaine hcl, menthol patch 
Binger Consulting Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Siterol

​​Drug Facts

Active ingredient

Lidocaine HCL 3.99%

Menthol 1.00%

Purpose

Topical Analgesic

External Analgesic

Keep out of reach of children. Consult physician for children under 12.

Uses

• temporary relief of pain associated with minor cuts, scrapes, and minor skin irritations

Warnings

For external use only

Do not use

• if pregnant or breastfeeding, consult physician prior to use

• in large quantities, particularly over raw surfaces or blistered areas

When using this product

• use only as directed • do not bandage tightly • avoid contact with eyes

• do not apply to open wounds or damaged skin

Stop use and ask a doctor if

• symptoms persist for more than seven days, discontinue use and consult physician

• swallowed, consult physician

Directions

How to apply • clean and dry affected area • remove patch from backing and apply to affected area • use only one patch at a time, and maximum of four patches/day • leave patch on affected area for upto 8-hours • do not use patches for longer than five consecutive days

Other ingredients aloe barbadensis leaf (aloe vera juice) gel, aqua (deionized water), arnica montana extract, boswellia serrata extract, camellia sinensis leaf (green tea) extract, carbomer, ethylhexylglycerin, glycerin, isopropyl myristate, PEG-8, phenoxyethanol, polysorbate-80, sodium lauryl sulfate, triethanolamine, FD C blue 1, FD C yellow 5

Questions or comments? ​call weekdays from 9 AM to 5 PM PST 888-501-5651

Other information store below 25°C (77° F), avoid direct sunlight

Packaging

Siterol

SITEROL 
lidocaine hcl, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69440-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.99 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-8 GLYCERYL ISOSTEARATE (UNII: 74QQ5X3KL1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69440-007-1515 in 1 BOX01/01/2015
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2015
Labeler - Binger Consulting Corporation (079635976)
Establishment
NameAddressID/FEIBusiness Operations
Active Intelligence, LLC080416593manufacture(69440-007)

Revised: 10/2021
Document Id: b553bb21-4705-45e1-a49b-336b022680db
Set id: 1ef21407-5fd2-4349-8d4f-af3b13dab476
Version: 4
Effective Time: 20211011
 
Binger Consulting Corporation