burn gel usa

burn gel usa
SPL v2
SPL
SPL Set ID 947ac362-acfb-3508-e053-2a95a90a2873
Route
topical
Published
Effective Date 2019-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
diazolidinyl urea water propylene glycol menthol alpha-tocopherol acetate trolamine aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-09

Purpose

Topical pain relief

Description

Lidocaine HCl 2.0%


Medication Information

Warnings

For external use only

Uses

Temporary pain relief for minor burns

Purpose

Topical pain relief

Directions
  • for adults and children 2 years and older: apply to affected area not more than 4 times daily
  • children under 2: do not use, consult a doctor
Inactive Ingredients
  • aloe vera
  • carbomer
  • germaben II
  • propylene glycol
  • purified water
  • menthol
  • triethanolamine
  • vitamin E acetate
Description

Lidocaine HCl 2.0%

Section 51945-4

REDICARE

BURN GEL

for minor burns, scalds & sunburn

WITH ALOE VERA FOR BEST RELIEF

3.5g / 1/8 oz.

NDC 71105-500-01

DRUG FACTS...

Do Not Use
  • In large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water.
Active Ingredient

Lidocaine HCl 2.0%

Stop Use and Ask Doctor

if condition worsens or persists for more than 7 days or clears up and occurs again within a few days

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away


Structured Label Content

Warnings

For external use only

Uses

Temporary pain relief for minor burns

Purpose

Topical pain relief

Directions
  • for adults and children 2 years and older: apply to affected area not more than 4 times daily
  • children under 2: do not use, consult a doctor
Inactive Ingredients
  • aloe vera
  • carbomer
  • germaben II
  • propylene glycol
  • purified water
  • menthol
  • triethanolamine
  • vitamin E acetate
Section 51945-4 (51945-4)

REDICARE

BURN GEL

for minor burns, scalds & sunburn

WITH ALOE VERA FOR BEST RELIEF

3.5g / 1/8 oz.

NDC 71105-500-01

DRUG FACTS...

Do Not Use (Do not use)
  • In large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water.
Active Ingredient

Lidocaine HCl 2.0%

Stop Use and Ask Doctor (Stop use and ask doctor)

if condition worsens or persists for more than 7 days or clears up and occurs 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 right away


Advanced Ingredient Data


Raw Label Data

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