Leader Lidocaine Hcl 4% Roll On

Leader Lidocaine Hcl 4% Roll On
SPL v4
SPL
SPL Set ID cece6765-0e2f-5ce9-e053-2995a90a3758
Route
TOPICAL
Published
Effective Date 2021-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Glyceryl Monostearate Aminomethylpropanol Ceteth-20 Phosphate Steareth-21 Ethylhexylglycerin Methylparaben Dicetyl Phosphate Dimethicone 350 Alcohol Aloe Vera Leaf Cetearyl Alcohol Edetate Disodium Water Caprylyl Methicone Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) C30-45 Alkyl Cetearyl Dimethicone Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-20

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

temporarily relieves pain and itching due to:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Description

Lidocaine HCl 4%

Section 34072-9

Flammable •Keep away from fire or flame

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

Section 51727-6

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

Section 51945-4

Leader

NDC 70000-0099-1

Maximum Strength

Lidocaine

Pain Relief

Liquid

Lidocaine HCl, 4% Topical Analgesic

No Mess

Applicator

Compare to

Aspercreme

Lidocaine liquid

active ingredient

100% Money Back Guarantee

2.5 Fl oz (73 mL)

Section 53413-1

call 515-276-1586

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Topical analgesic

Section 55106-9

Lidocaine HCl 4%

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Other Information

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


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves pain and itching due to:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Warnings and Precautions (34071-1)

For external use only

Section 34072-9 (34072-9)

Flammable •Keep away from fire or flame

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Leader

NDC 70000-0099-1

Maximum Strength

Lidocaine

Pain Relief

Liquid

Lidocaine HCl, 4% Topical Analgesic

No Mess

Applicator

Compare to

Aspercreme

Lidocaine liquid

active ingredient

100% Money Back Guarantee

2.5 Fl oz (73 mL)

Section 53413-1 (53413-1)

call 515-276-1586

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Other Information (Other information)

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


Advanced Ingredient Data


Raw Label Data

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