PAIN RELIEF PATCH - menthol, unspecified form and lidocaine hydrochloride patch 
Binger Consulting Corporation

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.

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Drug Facts

Other Ingredients   aloe barbadensis leaf (aloe vera juice) gel, aqua (deionized water), amica

montana extract, boswellia serrata extract, carmellia 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

Active Ingredient

Lidocaine HCL 4.00 %

Menthol 1.00 %

Purpose

Topical Analgesic

External Analgesic

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

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

Directions

How to apply   - clean and dry affected areas  - 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 up

to 8 hours  - do not use patches for longer than five consecutive days

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

Questions or comments?  call weekdays from 9 AM to 5 PM CST 800-914-7435

copy of label

PAIN RELIEF PATCH  
lidocaine, menthol patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69440-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:69440-004-01100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/201411/30/2015
Labeler - Binger Consulting Corporation (079635976)
Establishment
NameAddressID/FEIBusiness Operations
Binger Consulting Corporation 079635976relabel(69440-004)

Revised: 10/2015
 
Binger Consulting Corporation