Refill 3 (Benzalkonium Chloride, Lidocaine Hydrochloride) Cream [Cmc Group Inc.] -

REFILL 3 (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [CMC GROUP INC.]
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NDC	49687-0017-0
Set ID	e5cb395f-5037-4b0e-9c9d-2d78b5b01b25
Category	HUMAN OTC DRUG LABEL
Packager	CMC Group Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART333A

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Drug Facts
Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream
Uses
- First aid to help prevent infection in minor cuts, scrapes, and burns.
- For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Warnings

For external use only.

Do not use

• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
- Children under 2 years of age: consult a doctor
- May be covered with a sterile bandage
Other information

Store at room temperature
Inactive ingredients

glycerin monostearate, glycerol, purified water
Package Labeling:

INGREDIENTS AND APPEARANCE

REFILL 3
benzalkonium chloride, lidocaine hydrochloride cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49687-0017-0	10 in 1 BOX	08/10/2016
1		0.9 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/10/2016

Labeler - CMC Group Inc. (117201448)

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