CALM and CORRECT PAIN RELIEF SERUM

Active Ingredient

Lidocaine 3%

Purpose

External Analgesic

Uses

Temporarily relieves pain and itching due to

sunburn
minor burns
minor cuts
minor skin irritations

Warnings

For external use only

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

If swallowed - get medical help or contact a poison control center right away

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 Ingredients:

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

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

Oklahoma City, OK 73112

www.dermamedics.com

1 800 990 6552

DERMAMEDICS

Calm & Correct

Pain Relief

Serum with

3 % Lidocaine

When using this product

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

Avoid contact with the eyes

BOX ART BOTTLE ART AND BOX ART

BOTTLE ART

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M015	08/02/2022

Labeler - Renu Laboratories, Inc. (945739449)

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