Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID c6a0880e-fc16-46e9-8314-c56c9d15bf31
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Water Glycerin Petrolatum Cetyl Alcohol Stearic Acid Shea Butter Cetostearyl Alcohol Isopropyl Myristate Glyceryl Monostearate Peg-100 Stearate Dimethicone Palmitic Acid Myristic Acid Ceramide 3 Ceramide 6 Ii Ceramide 1 Phenoxyethanol Behentrimonium Methosulfate Xanthan Gum Sodium Hydroxide Alcohol Ethylhexylglycerin Sodium Lauroyl Lactylate Edetate Disodium Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Tasmannia Lanceolata Fruit Phytosphingosine Cholesterol Hyaluronic Acid Citric Acid Monohydrate Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-18

Description

Pramoxine hydrochloride 1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Pramoxine hydrochloride 1%

Use

For the temporary relief of itching associated with minor skin irritations.

Section 50566-9

Section 50567-7

Section 51945-4

Warnings

For external use only

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor.

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Pramoxine hydrochloride 1%

Inactive Ingredients



water, glycerin, petrolatum, cetyl alcohol, butyrospermum parkii (shea) butter, cetearyl alcohol, PEG-100 stearate, glyceryl stearate, isopropyl myristate, stearic acid, dimethicone, palmitic acid, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, behentrimonium methosulfate, sodium hydroxide, myristic acid, sodium lauroyl lactylate, cholesterol, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., hydrolyzed hyaluronic acid, citric acid, xanthan gum, hytosphingosine, ethylhexylglycerin

Questions Or Comments?

Toll-Free Number 888-768-2915

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last 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

Use

For the temporary relief of itching associated with minor skin irritations.

Section 50566-9 (50566-9)

Section 50567-7 (50567-7)

Section 51945-4 (51945-4)

Purpose

External analgesic

Warnings

For external use only

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor.

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Pramoxine hydrochloride 1%

Inactive Ingredients (Inactive ingredients)



water, glycerin, petrolatum, cetyl alcohol, butyrospermum parkii (shea) butter, cetearyl alcohol, PEG-100 stearate, glyceryl stearate, isopropyl myristate, stearic acid, dimethicone, palmitic acid, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, behentrimonium methosulfate, sodium hydroxide, myristic acid, sodium lauroyl lactylate, cholesterol, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., hydrolyzed hyaluronic acid, citric acid, xanthan gum, hytosphingosine, ethylhexylglycerin

Questions Or Comments? (Questions or comments?)

Toll-Free Number 888-768-2915

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last 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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