PAIN RELIEF ROLL ON EVORA LABS- lidocaine liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Available from:
Evora Worldwide
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Lidocaine 4%..................................................... Topical analgesic For temporary relief of pain and itching
Authorization status:
OTC monograph not final
Authorization number:
77375-007-02

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PAIN RELIEF ROLL ON EVORA LABS- lidocaine liquid

Evora Worldwide

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.

----------

Pain Releif Lidocaine 4%

Active ingredient Purpose

Lidocaine 4%..................................................... Topical analgesic

Us es

For temporary relief of pain and itching

Warnings

For externa use only.

When using this product use only as directed do not bandage tightly avoid contact with

eyes do not apply to wounds or damaged skin do not use in large quantities, particularly over raw

surface or blistered areas.

Stop use and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and

occur again within a few days

Flammable keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before

use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily

Children under 2 years old: consult a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

ALOE VERA LEAF

AMINOMETHYLPROPANOL

Caprylyl Methicone

CETOSTEARYL ALCOHOL

CETETH-20 PHOSPHATE

DIHEXADECYL PHOSPHATE

DIMETHICONE

EDETATE DISODIUM

Ethylhexylglycerin

GLYCERYL STEARATE

METHYLPARABEN

SD ALCOHOL 40

STEARETH-21

WATER

Ques tions ?

1-888-793-8450

PAIN RELIEF ROLL ON EVORA LABS

lidocaine liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:77375-0 0 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Evora Worldwide

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

4 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

MYRISTYL TRISILO XANE (UNII: J79 6 0 S4R1T)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETETH-2 0 PHO SPHATE (UNII: 9 21FTA150 0 )

DIHEXADECYL PHO SPHATE (UNII: 2V6 E5WN9 9 N)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

STEARETH-2 1 (UNII: 53J3F32P58 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:77375-0 0 7-

1 in 1 CARTON

12/22/20 20

1

74 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

12/22/20 20

Labeler -

Evora Worldwide (081336028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Inspec So lutio ns LLC

0 8 10 30 372

ma nufa c ture (77375-0 0 7)

Revised: 12/2020

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