Qc Medicated Anti Itch Cream

Qc Medicated Anti Itch Cream
SPL v2
SPL
SPL Set ID b5e41e3a-81df-3a63-e053-2a95a90a5839
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Pramoxine
Inactive Ingredients
Water Diazolidinyl Urea Trolamine Steareth-21 Petrolatum Methylparaben Propylparaben Sodium Polyacrylate (8000 Mw) Propylene Glycol Methyl Salicylate Edetate Disodium Aloe Vera Leaf Stearyl Alcohol Eucalyptus Oil .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-07

Description

Menthol 1% Pramoxine hydrochloride 1%

Purpose

Topical anagesic


Medication Information

Purpose

Topical anagesic

Description

Menthol 1% Pramoxine hydrochloride 1%

Uses

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Dosage

Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

Warnings

For external use only

Directions

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

children under 2 years: consult a doctor

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

Other Information

store at controlled room temperature

Inactive Ingredients

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

Package Principal Panel

When Using This Product

do not get into eyes

Keep Out of Reach of Children

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


Structured Label Content

Uses

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Dosage

Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

Purpose

Topical anagesic

Warnings

For external use only

Directions

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

children under 2 years: consult a doctor

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

Other Information

store at controlled room temperature

Inactive Ingredients

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

Package Principal Panel (Package principal panel)

When Using This Product (When using this product)

do not get into eyes

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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