CALM AND CORRECT SERUM WITH LIDOCAINE- lidocaine 3 percent liquid

Calm and Correct Serum with Lidocaine by

Drug Labeling and Warnings

Calm and Correct Serum with Lidocaine by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine 3%

PURPOSE

Purpose

External Analgesic

INDICATIONS & USAGE

Uses

Temporarily relieves pain and itching due to

• sunburn
• minor burns
• minor cuts
• minor skin irritations

WARNINGS

Warnings

For external use only

STOP USE

Stop use and ask a doctor if

• Condition gets worse
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again in a few days

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 to affected area not more than 3 to 4 times daily
• children under 2 years of age : ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.

OTHER SAFETY INFORMATION

Manufactured in the U.S.A. for Dermamedics, LLC

Oklahoma City, OK 73112

www.dermamedics.com

1 800 990 6552

STATEMENT OF IDENTITY

DERMAMEDICS

Calm & Correct

Pain Relief

Serum with

3 % Lidocaine

WHEN USING

When using this product

Do not use in large quantities particularly over raw surfaces or blistered areas

Avoid contact with the eyes

PRINCIPAL DISPLAY PANEL

BOTTLE ART AND BOX ART

INGREDIENTS AND APPEARANCE

CALM AND CORRECT SERUM WITH LIDOCAINE 
lidocaine 3 percent liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISOEUGENYL ACETATE (UNII: 9DF21GI8W6)
JOJOBA OIL (UNII: 724GKU717M)
DIHYDROEUGENOL (UNII: A3XE712277)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-725-01	1 in 1 BOX	08/02/2022
1	NDC: 76348-725-50	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M015	08/02/2022

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-725)