Dermend Moisturizing Anti-itch Lotion

Dermend Moisturizing Anti-itch Lotion
SPL v2
SPL
SPL Set ID 14c7fb1c-a310-4b12-ab2e-7f1c0801995c
Route
TOPICAL
Published
Effective Date 2017-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Cetyl Alcohol Diisopropyl Adipate Dimethicone Glycerin Petrolatum Lanolin Hydrogenated Coconut Oil Sorbitan Sesquioleate Stearyl Alcohol Mineral Oil Polyoxyl 40 Stearate Potassium Sorbate Povidone Water Sorbic Acid Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-01

Description

Pramoxine HCl 1% w/w

Purpose

external analgesic


Medication Information

Purpose

external analgesic

Description

Pramoxine HCl 1% w/w

Use

for the temporary relief of itching associated with minor skin irritations

Warnings

For external use only.

Avoid contact with the eyes.

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
Package Label

NDC 0496-0586-08

8oz (237mL)

Active Ingredient

Pramoxine HCl 1% w/w

Inactive Ingredients

cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine

Stop Use and Ask A Doctor If
  • conditions 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, seek medical attention or contact a Poison Cotrol Center right away.


Structured Label Content

Use

for the temporary relief of itching associated with minor skin irritations

Purpose

external analgesic

Warnings

For external use only.

Avoid contact with the eyes.

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
Package Label

NDC 0496-0586-08

8oz (237mL)

Active Ingredient (Active ingredient)

Pramoxine HCl 1% w/w

Inactive Ingredients (Inactive ingredients)

cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions 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, seek medical attention or contact a Poison Cotrol Center right away.


Advanced Ingredient Data


Raw Label Data

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