RESTORE LIDOCAINE PAIN RELIEF CREAM- lidocaine cream

Restore Lidocaine Pain Relief Cream by

Drug Labeling and Warnings

Restore Lidocaine Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Purpose

Topical anesthetic

INDICATIONS & USAGE

Uses: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.

WARNINGS

For External Use only

WHEN USING

When using this product, do not use in or near the eyes

• do not use in large quantities, particularly over raw surfaces or blistered areas.

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.

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: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day

Children under 2 years, ask a doctor

OTHER SAFETY INFORMATION

May be applied under occlusive dressing

Store at 20 - 25° C

QUESTIONS

support@restoriden.com

INACTIVE INGREDIENT

Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol

PRINCIPAL DISPLAY PANEL

RESTORE JAR LABEL AND

RESTORE BOX

INGREDIENTS AND APPEARANCE

RESTORE LIDOCAINE PAIN RELIEF CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.24 g  in 56 g

Inactive Ingredients
Ingredient Name	Strength
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
JOJOBA OIL (UNII: 724GKU717M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-605-01	1 in 1 BOX	05/05/2021
1	NDC: 76348-605-02	56 g in 1 JAR; 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	05/05/2021

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-605)