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NDC 49687-0014-00 Burn Treatment .13; .5 g/100g; g/100g Details

Burn Treatment .13; .5 g/100g; g/100g

Burn Treatment is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by CMC Group Inc.. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	49687-0014
Product ID	49687-0014_b856a95e-6be8-d0f8-e053-2a95a90af28b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Burn Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.13; .5
Active Ingredient Units	g/100g; g/100g
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Labeler Name	CMC Group Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 49687-0014-00 (49687001400)

Pricing Information	N/A
NDC Package Code	49687-0014-0
Billing NDC	49687001400
Package	10 POUCH in 1 KIT (49687-0014-0) / .9 g in 1 POUCH
Marketing Start Date	2016-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 Details

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

BURN TREATMENT

benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0014
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49687-0014-0	10 in 1 KIT	08/06/2016
1		0.9 g in 1 POUCH; 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	08/06/2016

Labeler - CMC Group Inc. (117201448)

Revised: 1/2021

Document Id: b856a95e-6be8-d0f8-e053-2a95a90af28b

Set id: 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40

Version: 5

Effective Time: 20210107