SITEROL- lidocaine hcl, menthol patch

Siterol by

Drug Labeling and Warnings

Siterol by is a Otc medication manufactured, distributed, or labeled by Binger Consulting Corporation, Pocono Coated Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​​Drug Facts

Active ingredient

Lidocaine HCL 3.99%

Menthol 1.00%

Purpose

Topical Analgesic

External Analgesic

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

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

STORAGE AND HANDLING

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

Packaging

INGREDIENTS AND APPEARANCE

SITEROL 
lidocaine hcl, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69440-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	3.99 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69440-007-15	15 in 1 BOX	01/01/2015
1		100 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2015

Labeler - Binger Consulting Corporation (079635976)

Establishment
Name	Address	ID/FEI	Business Operations
Pocono Coated Products, LLC		362785771	manufacture(69440-007)