Leader Lidocaine Hcl 4% Cream

Leader Lidocaine Hcl 4% Cream
SPL v2
SPL
SPL Set ID cea6bd2d-a265-1209-e053-2995a90ab0a5
Route
TOPICAL
Published
Effective Date 2021-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Edetate Disodium Dihexadecyl Phosphate Dimethicone 350 Aloe Vera Leaf Cetostearyl Alcohol Methylparaben Ethylhexylglycerin Aminomethylpropanol Glyceryl Stearate Se Ceteth-20 Phosphate Steareth-21 Caprylyl Trisiloxane Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-18

Description

Lidocaine HCl 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine HCl 4%

Uses

temporarily relieves pain and itching due to:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product do not get into eyes

Section 50570-1

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

Warnings

For external use only

Directions
  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor
Active Ingredient

Lidocaine HCl 4%

Other Information

store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,

C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Principal Display Panel

Leader

NDC 70000-0098-1

Maximum Strength

Lidocaine

Pain Relief

Cream

Lidocaine HCl 4% Topical Analgesic

Non Greasy

Compare to aspercreme lidocaine cream

active ingredient

100% Money Back Guarantee

Net wt 2.7 oz (76.5g)


Structured Label Content

Uses

temporarily relieves pain and itching due to:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 50570-1 (50570-1)

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

Purpose

Topical analgesic

Warnings

For external use only

Directions
  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor
Active Ingredient (Active ingredient)

Lidocaine HCl 4%

Other Information (Other information)

store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,

C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Principal Display Panel (Principal display panel)

Leader

NDC 70000-0098-1

Maximum Strength

Lidocaine

Pain Relief

Cream

Lidocaine HCl 4% Topical Analgesic

Non Greasy

Compare to aspercreme lidocaine cream

active ingredient

100% Money Back Guarantee

Net wt 2.7 oz (76.5g)


Advanced Ingredient Data


Raw Label Data

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