1168 burn spray

1168 burn spray
SPL v1
SPL
SPL Set ID 1183a4f5-f875-dfb0-e063-6394a90af35f
Route
topical
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
melaleuca alternifolia (tea tree) leaf oil water octoxynol 9 polyoxyl 40 hydrogenated castor oil glycerin phenoxyethanol trolamine hypromellose, unspecified propylene glycol

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
otc monograph drug active Since 2024-02-29

Purpose

Topical Analgesic

Description

Lidocaine Hydrochloride 2%


Medication Information

Warnings

For External Use Only

Purpose

Topical Analgesic

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

Description

Lidocaine Hydrochloride 2%

Questions?

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

Label

1168 Label

Use(s)

For the temporary relief of pain associated with minor burns

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.

Active Ingredient

Lidocaine Hydrochloride 2%

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.


Structured Label Content

Warnings

For External Use Only

Purpose

Topical Analgesic

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

Use(s)

For the temporary relief of pain associated with minor burns

Do Not Use (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.

Active Ingredient

Lidocaine Hydrochloride 2%

Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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