LIDOPLUS PAIN RELIEF- lidocaine hydrochloride cream

Centura Pharmaceuticals , Inc

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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LidoPlus Pain Relief Cream

Drug Facts

Active Ingredients:
Lidocaine HCl 4.00%

Topical Anesthetic

Indications:
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes,
insect bites and minor skin irritations.

Warnings:
For external us e only.
• Avoid contact with eyes. • If condition worsens or symptoms persist for more than seven days,
discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not us e
in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breas t feeding,

contact physician prior to use.

Directions:
• Adults and children two-years of age or older: Apply to affected area not more than three to four
times daily.
• Children under two-years of age: consult a physician.

Other Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower
Extract, Boswellia Serrata Extract, C13-14 Isoparaffin, Cetyl Alcohol, Chondroitin Sulfate, Dimethyl
Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Stearate, Glycerin, Hamamelis
Virginiana (Witch Hazel) Extract, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,
Polysorbate-20, Stearic Acid.
Package Labeling:

LIDOPLUS PAIN RELIEF

lidocaine hydrochloride cream

Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:70 372-723

Route of Ad minis tration TO PICAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th
LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDO CAINE - LIDO CAINE 40 mg
UNII:9 8 PI20 0 9 8 7) HYDRO CHLO RIDE in 1 mL

Inactive Ing redients

Ing redient Name Streng th
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
WATER (UNII: 0 59 Q F0 KO 0 R)
ARNICA MO NTANA FLO WER (UNII: O Z0 E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41Q CO 2M)
C13 -14 ISO PARAFFIN (UNII: E4F12RO E70 )
 CETYL ALCO HO L (UNII: 9 36 JST6 JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCO SAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERYL MO NO STEARATE (UNII: 230 O U9 XXE4)
GLYCERIN (UNII: PDC6 A3C0 O X)
HAMAMELIS VIRGINIANA TO P (UNII: UDA30 A2JJY)
LAURETH-7 (UNII: Z9 5S6 G8 20 1)
PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)
PHENO XYETHANO L (UNII: HIE49 2ZZ3T)
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)
STEARIC ACID (UNII: 4ELV7Z6 5AP)

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:70 372-723-0 1 1 in 1 BO X 0 2/0 7/20 17
1 118 mL in 1 TUBE; Type 0 : No t a Co mbina tio n Pro duc t

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
O TC mo no gra ph no t fina l pa rt348 12/25/20 15

Labeler - Centura Pharmaceuticals , Inc (084921637)

Revised: 2/2017 Centura Pharmaceuticals, Inc