KONICARE 5%- konicare 5% lido spray spray

KONICARE 5% by

Drug Labeling and Warnings

KONICARE 5% by is a Otc medication manufactured, distributed, or labeled by Turkuaz Saglik Hizmetleri Medikal Temizlik KImyasal Urunler Sanayi ve Tic. AS, Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

• Ethyl Alcohol 2,5 %.........Topical Anesthetic
• Lidocaine HCl 5%............Topical Anesthetic

INDICATIONS & USAGE

Uses:

For temporary relief of pain

WARNINGS

Do not use

On wounds or damaged skin

In large quantities

With a heating pad

If you are allergic to any ingredients of this product

Stop use and ask a doctor if,

Use only as directed

Avoid contact with the eyes, mucous membranes or rashes

Do not bandage tightly

Stop use and ask a doctor if,

Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

Conditions worsen

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

If pregnant or breast feeding,

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

Keep out of reach of children

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

Directions

Adults and children 12 years of age and older:

• Clean and dry affected area
• Apply to affected area not more than 4 times daily

Children under 12 years of age:

• Consult a doctor

Inactive Ingredients:

Water, Citric Acid, Methy Hydroxy Benzoate, Benzalkonium Chloride.

Konicare 5% LidoSpray

Ethyl Alcohol 2.5 % Topical Anesthetic
Lidocaine HCl 5% Topical Anesthetic

INGREDIENTS AND APPEARANCE

KONICARE 5% 
konicare 5% lido spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73107-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73107-902-10	1 in 1 CARTON	11/01/2019
1		40 mL in 1 PACKAGE; 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	11/01/2019

Labeler - Turkuaz Saglik Hizmetleri Medikal Temizlik KImyasal Urunler Sanayi ve Tic. AS (356325295)

Registrant - Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler (356325295)

Establishment
Name	Address	ID/FEI	Business Operations
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler		356325295	manufacture(73107-902)