Pain Relief Roll-on

Pain Relief Roll-on
SPL v2
SPL
SPL Set ID f607b6dc-8d13-604a-e053-2995a90a59ab
Route
TOPICAL
Published
Effective Date 2023-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aminomethylpropanol Water Steareth-21 Alcohol Methylparaben Caprylyl Trisiloxane Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Glyceryl Monostearate Ethylhexylglycerin Edetate Disodium Anhydrous Dihexadecyl Phosphate Ceteth-20 Phosphate Dimethicone Cetostearyl Alcohol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-20

Description

Lidocaine 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine 4%

Uses

For temporarily relief of pain and itching.

Warnings

For external use only.

Directions

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Carton Label

*compare to the active ingredient

in Aspercreme® Odor Free

with 4 % Lidocaine

NDC 69452-393-63

a+health™

maximum strength

pain relief

roll-on

lidocaine 4% HCl/

topical analgesic

odor free

no mess applicator

  • temporarary relief of pain
  • helps pain-affected areas

without irritation

2.5 fl oz (74mL)

with aloe

Active Ingredient

Lidocaine 4%

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, polysorbate 60, SD Alcohol 40, Steareth-21, Purified Water

When Using This Product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use in large quantities, particularly over raw surfaces or blistered areas
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 a Poison Control Center immediately.


Structured Label Content

Uses

For temporarily relief of pain and itching.

Purpose

Topical analgesic

Warnings

For external use only.

Directions

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Carton Label

*compare to the active ingredient

in Aspercreme® Odor Free

with 4 % Lidocaine

NDC 69452-393-63

a+health™

maximum strength

pain relief

roll-on

lidocaine 4% HCl/

topical analgesic

odor free

no mess applicator

  • temporarary relief of pain
  • helps pain-affected areas

without irritation

2.5 fl oz (74mL)

with aloe

Active Ingredient (Active ingredient)

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, polysorbate 60, SD Alcohol 40, Steareth-21, Purified Water

When Using This Product (When using this product)

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A 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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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