Drugplain

1168 .02 mg/mL

1168 Burn Spray · SPRAY · Dynarex Corporation

No Recall History
Plain English

1168 is a spray containing 1168 burn spray at .02 mg/mL, taken topical. Manufactured by Dynarex Corporation.

Key Facts

Brand Name
1168
Generic Name
1168 Burn Spray
NDC Code (Product)
67777-013
Manufacturer
Dynarex Corporation
Strength
.02 mg/mL
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
02/29/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea287 reports
weight decreased176 reports
vomiting166 reports
dizziness160 reports
fatigue151 reports
drug ineffective148 reports
blood glucose increased143 reports
dyspnoea135 reports
diarrhoea128 reports
headache127 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) For the temporary relief of pain associated with minor burns

Dosage & Administration

Directions • Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily. • Children under 12 years of age: Consult a doctor before use

Warnings

Warnings For External Use Only Do not use • Over large areas of the body, particularly over raw surfaces, or blistered areas • Near eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is 1168 used for?

1168 contains 1168 Burn Spray. It is a spray taken topical. Consult your doctor for specific uses.

Is 1168 a controlled substance?

1168 is not classified as a controlled substance by the DEA.

What is the generic name for 1168?

The generic name for 1168 is 1168 Burn Spray. There are no other listed brand versions of 1168 Burn Spray.

What is the NDC code for 1168 .02 mg/mL?

The NDC (National Drug Code) for 1168 .02 mg/mL is 67777-013, listed by Dynarex Corporation.

Product NDC

67777-013

Package NDC

67777-013-05

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)