Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 mg)
Inactive Ingredients
Water Isopropyl Myristate Cetyl Alcohol Stearic Acid Cetostearyl Alcohol Glyceryl Monostearate Peg-100 Stearate Glycerin Dimethicone Niacinamide Ceramide 3 Ceramide 6 Ii Ceramide 1 Phenoxyethanol Xanthan Gum Behentrimonium Methosulfate Polyglyceryl-3 Diisostearate Sodium Hydroxide Allantoin Ethylhexylglycerin Sodium Lauroyl Lactylate Arginine Pyroglutamate Edetate Disodium Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Zinc Citrate Sodium Pyrrolidone Carboxylate Phytosphingosine Cholesterol Myristic Acid Palmitic Acid Hyaluronic Acid Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-17

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 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

Questions?

Toll-Free Number 888-768-2915

www.cerave.com

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

Pramoxine hydrochloride 1%

Inactive Ingredients

water, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin

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 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

Questions?

Toll-Free Number 888-768-2915

www.cerave.com

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, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin

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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