PAIN RELIEF- lidocaine and menthol cream

PAIN RELIEF by

Drug Labeling and Warnings

PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

LIDOCAINE 4%

MENTHOL 1.25%

PURPOSE

TOPICAL ANESTHETIC

INDICATIONS & USAGE

Temporarily relieves minor pain, itching and irritation due to/associated with:

• ARTHRITIS
• SIMPLE BACKACHE
• MUSCLE STRAINS
• SPRAINS
• BRUISES
  
• MINOR CUTS/SCRAPES
• MINOR BURNS/SUNBURN
• INSECT BITES

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USE

• IF YOU ARE ALLERGIC TO ANY TYPE OF NUMBING MEDICINE
• IN LARGE QUANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS
• ON INFECTIONS
  
• ON DEEP PUNCTURE WOUNDS
• ON RAW SURFACES OR BLISTERED AREAS

WHEN USING

WHEN USING THIS PRODUCT

• DO NOT USE OVER LARGE SKIN AREAS
• DO NOT APPLY HEAT, BANDAGES OR PLASTIC WRAP TO TREATED AREAS
  
• DO NOT USE IN OR NEAR THE EYES
• WASH HANDS IMMEDIATELY AFTER USING

STOP USE

STOP USE AND ASK A DOCTOR IF

• ALLERGIC REACTION OCCURS
• CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
• SYMPTOMS CLEAR UP AND RETURN WITHIN A FEW DAYS
• REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS BEGIN OR INCREASE.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS:

• APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 3 TO 4 TIMES A DAY. FOR USE ON ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER. CHILDREN UNDER 2 YEARS - ASK A DOCTOR.
  

INACTIVE INGREDIENT

Inactive ingredients: allantoin, aloe barbadensis (AP4® genuine virgin organic aloe vera) leaf extract, arnica montana flower extract, boswellia serrata gum, butyrospermum parkii (shea butter), calophyllum tacamahaca fruit (tamanu nut) oil, carbomer, cetearyl alcohol, chamomilla recutita matricaria (chamomile) extract, glyceryl stearate, hypericum perforatum (st. john’s wort), isopropyl palmitate, persea gratissima (avocado) oil, phenoxyethanol, polysorbate-60, sodium polyacrylate, squalane, stearyl alcohol, trideceth-6

PREGNANCY OR BREAST FEEDING

DO NOT USE

• IF PREGNANT OR BREAST FEEDING
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
lidocaine and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
SHEA BUTTER (UNII: K49155WL9Y)
CALOPHYLLUM TACAMAHACA WHOLE (UNII: 179EAP33MM)
CARBOMER 934 (UNII: Z135WT9208)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
AVOCADO OIL (UNII: 6VNO72PFC1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SQUALANE (UNII: GW89575KF9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-201-54	1 in 1 BOX	01/03/2014
1	NDC: 10738-201-12	62 g in 1 TUBE; 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	01/03/2014

Labeler - Genuine Virgin Aloe Corporation (743159706)

Registrant - Genuine Virgin Aloe Corporation (743159706)