First° Degree®

Drug Facts

Composition & Product

Active Ingredients

Pramoxine (10 mg)

Inactive Ingredients

Shea Butter Calendula Officinalis Flowering Top Lytta Vesicatoria Guar Gum Echinacea Angustifolia Alcohol Hydrogenated Polydecene (550 Mw) Isopropyl Myristate Lanolin Lanolin Alcohols Petrolatum Phenoxyethanol Water Sodium Hydroxide Sodium Taurate Trideceth-10

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-03-09

Medication Information

Purpose

External analgesic

Description

Drug Facts

Uses

For the temporary relief of pain and itching associated with:

minor burns
insect bites
sunburns
minor cuts
scrapes
minor skin irritations

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only. Avoid contact with the eyes

Directions

adults and children 2 years of age and older:
- clean the affected area
- apply to affected area not more than 3 to 4 times daily
- may be covered with a sterile bandage
children under 2 years of age: ask a doctor

Do Not Use

if you are allergic to any of the ingredients
over large areas of the body

Active Ingredient

Pramoxine HCL 1%

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10

Questions Or Comments?

1-888-565-2876

Monday through Friday, 9am-5pm EST

Stop Use and Ask A Doctor If

condition worsens
symptoms persist for more than 1 week, or clear up and occur again within a few days
rash or other allergic reaction develops

Principal Display Panel 21 G Tube Box

NEW &

IMPROVED!

First°Degree^®

MAXIMUM STRENGTH

BURN CREAM

PRAMOXINE HCL 1% PAIN RELIEVING CREAM

FAST RELIEF FOR

PAIN + ITCH

GREAT FOR

MINOR

BURNS

BUG

BITES
HELPS REDUCE THE APPEARANCE OF SCARS
ENRICHED WITH NOURISHING BOTANICALS

1 Tube

Net Wt 3/4 oz (21 g)

Structured Label Content

Uses

For the temporary relief of pain and itching associated with:

minor burns
insect bites
sunburns
minor cuts
scrapes
minor skin irritations

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

External analgesic

Warnings

For external use only. Avoid contact with the eyes

Directions

adults and children 2 years of age and older:
- clean the affected area
- apply to affected area not more than 3 to 4 times daily
- may be covered with a sterile bandage
children under 2 years of age: ask a doctor

Do Not Use (Do not use)

if you are allergic to any of the ingredients
over large areas of the body

Active Ingredient (Active ingredient)

Pramoxine HCL 1%

Other Information (Other information)

store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10

Questions Or Comments? (Questions or Comments?)

1-888-565-2876

Monday through Friday, 9am-5pm EST

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

condition worsens
symptoms persist for more than 1 week, or clear up and occur again within a few days
rash or other allergic reaction develops

Principal Display Panel 21 G Tube Box (PRINCIPAL DISPLAY PANEL - 21 g Tube Box)

NEW &

IMPROVED!

First°Degree^®

MAXIMUM STRENGTH

BURN CREAM

PRAMOXINE HCL 1% PAIN RELIEVING CREAM

FAST RELIEF FOR

PAIN + ITCH

GREAT FOR

MINOR

BURNS

BUG

BITES
HELPS REDUCE THE APPEARANCE OF SCARS
ENRICHED WITH NOURISHING BOTANICALS

1 Tube

Net Wt 3/4 oz (21 g)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of pain and itching associated with: minor burns insect bites sunburns minor cuts scrapes minor skin irritations", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "External analgesic", "Warnings": "For external use only. Avoid contact with the eyes", "Directions": "adults and children 2 years of age and older: clean the affected area apply to affected area not more than 3 to 4 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor", "Do not use": "if you are allergic to any of the ingredients over large areas of the body", "Active ingredient": "Pramoxine HCL 1%", "Other information": "store at 20-25°C (68-77°F)", "Inactive ingredients": "butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10", "Questions or Comments?": "1-888-565-2876 Monday through Friday, 9am-5pm EST", "Stop use and ask a doctor if": "condition worsens symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops", "PRINCIPAL DISPLAY PANEL - 21 g Tube Box": "NEW & IMPROVED! First° Degree ® MAXIMUM STRENGTH BURN CREAM PRAMOXINE HCL 1% PAIN RELIEVING CREAM FAST RELIEF FOR PAIN + ITCH GREAT FOR MINOR BURNS BUG BITES HELPS REDUCE THE APPEARANCE OF SCARS ENRICHED WITH NOURISHING BOTANICALS 1 Tube Net Wt 3/4 oz (21 g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information