After Burn

After Burn
SPL v1
SPL
SPL Set ID 4640395f-a76c-d022-e063-6294a90adde6
Route
TOPICAL
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (1.14 g)
Inactive Ingredients
Glycerin Water Benzalkonium Chloride Carbomer Homopolymer, Unspecified Type Polysorbate 20 Sodium Hydroxide Menthol Carbomer 980 Propylene Glycol Aloe Vera Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-11

Description

Active Ingredient Lidocaine Hydrochloride 2.50%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Active Ingredient Lidocaine Hydrochloride 2.50%

Uses

For the temporary relief of pain due to minor burns, sunburns, minor cuts, scrapes, or minor skin irritations

Warnings

for external use only

Directions

Clean rg affected area.

Adults and children 2 years of age and older apply a small amount to affected area not more than 3 times daily.

Children under 2 years of age consult a doctor

If in Eyes

flush with water for 15 minutes and call a doctor

Active Ingredient

Active Ingredient

Lidocaine Hydrochloride 2.50%

Inactive Ingredients

Aloe Vera, Benzalkonium Chloride, Carbomer 980, GLycerol USP, Herbal Fragrance, Menthol, Polysorbate 20, Propylene Glycol, Purified Water, Sodium Hydroxide

When Using This Product

avoid contact with eyes

do not use in large quantities, particularly over raw surfaces or blistered areas

do not use longer than 1 week unless directed by doctor

Stop Use and Ask A Doctor If

Condition worsens

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 poisn control center right away.

After Burn Primary Packaging Label

Secondary Packaging After Burn Box


Structured Label Content

Uses

For the temporary relief of pain due to minor burns, sunburns, minor cuts, scrapes, or minor skin irritations

Purpose

Topical Analgesic

Warnings

for external use only

Directions

Clean rg affected area.

Adults and children 2 years of age and older apply a small amount to affected area not more than 3 times daily.

Children under 2 years of age consult a doctor

If in Eyes (If in eyes)

flush with water for 15 minutes and call a doctor

Active Ingredient

Active Ingredient

Lidocaine Hydrochloride 2.50%

Inactive Ingredients

Aloe Vera, Benzalkonium Chloride, Carbomer 980, GLycerol USP, Herbal Fragrance, Menthol, Polysorbate 20, Propylene Glycol, Purified Water, Sodium Hydroxide

When Using This Product (When using this product)

avoid contact with eyes

do not use in large quantities, particularly over raw surfaces or blistered areas

do not use longer than 1 week unless directed by doctor

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

Condition worsens

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 poisn control center right away.

After Burn Primary Packaging Label

Secondary Packaging After Burn Box


Advanced Ingredient Data


Raw Label Data

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