1168- 1168 burn spray spray

1168 by

Drug Labeling and Warnings

1168 by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine Hydrochloride 2%

Purpose

Topical Analgesic

Use(s)

For the temporary relief of pain associated with minor burns

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.

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

Other Information

Store at 20º-25ºC (68º-77°F)

Inactive Ingredients

Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine

Questions?

1-888-Dynarex Monday - Friday, 9AM - 5PM EST

Label

1168 Label

INGREDIENTS AND APPEARANCE

1168 
1168 burn spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-013-05	24 in 1 CASE	02/29/2024
1	NDC: 67777-013-06	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/29/2024

Labeler - Dynarex Corporation (008124539)