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NDC 70704-0212-35 burn solution cream 10 mg/mL Details

burn solution cream 10 mg/mL

burn solution cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Burn Solution Foundations. The primary component is TETRACAINE.

Product Information

NDC	70704-0212
Product ID	70704-212_c0e3c44c-b7bf-da89-e053-2a95a90a3482
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 solution cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Tetracaine cream
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	TETRACAINE
Labeler Name	Burn Solution Foundations
Pharmaceutical Class	Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70704-0212-35 (70704021235)

Pricing Information	N/A
NDC Package Code	70704-212-35
Billing NDC	70704021235
Package	12 TUBE in 1 BOX (70704-212-35) / 10 mL in 1 TUBE (70704-212-34)
Marketing Start Date	2016-08-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b95bad36-668d-0954-e053-2995a90ab0f3 Details

Drug Facts

Topical Burn Cream plus Pain Relief

Active ingredient

Tetracaine (1.0%).......................Pain & Itch Relief

Purpose

For temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, sprains, and burns

Indications

• For cooling, deep-penetrating pain relief, apply a thin layer sparingly to affected areas.

• Apply up to 3 times daily

Warnings

• Not for use on children under 2 years old except as directed by a doctor.

• Avoid contact with the eyes.

• For external use only.

• If irritation develops and persists, discontinue use and consult a doctor.

• If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Directions

• Apply this product topically to affected areas.

• Use up to 3 times daily.

• Use only as directed.

Other Information

External Anesthetic

Inactive Ingredients

Water, Stearic Acid, Lauramide DEA, Beeswax, Propylene Glycol, Sodium Tetraborate, Sodium Lauryl Sulfate, Diazolidinyl Urea,

Methylparaben, Propylparaben, Triethanolamine, Eucalyptus Oil.

Questions or Comments

Burn Solution Foundation

Land O Lakes, FL

888.368.0555

http://relief-roller.com

PRINCIPAL DISPLAY PANEL

starell

INGREDIENTS AND APPEARANCE

BURN SOLUTION CREAM

tetracaine cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70704-212
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BORATE ANHYDROUS (UNII: 8191EN8ZMD)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70704-212-20	1 in 1 BOX	02/02/2021
1		5.6 mL in 1 TUBE; 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	part348	02/02/2021

Labeler - Burn Solution Foundations (085996883)

Name	Address	ID/FEI	Business Operations
Establishment
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(70704-212)

Revised: 4/2021

Document Id: c0e3c44c-b7bf-da89-e053-2a95a90a3482

Set id: b95bad36-668d-0954-e053-2995a90ab0f3

Version: 3

Effective Time: 20210426