armand medicated anti itch cream

armand medicated anti itch cream
SPL v5
SPL
SPL Set ID 86986d05-8830-0853-e053-2a91aa0a4b14
Route
topical
Published
Effective Date 2014-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pramoxine (1 g) menthol
Inactive Ingredients
steareth-21 .alpha.-tocopherol acetate, dl- sodium acrylate mineral oil edetic acid trolamine propylene glycol methyl salicylate aloe vera leaf water petrolatum stearyl alcohol ppg-1 trideceth-6 eucalyptus oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph not final active Since 2014-04-13

Purpose

Topical anagesic

Description

Menthol 1% Pramoxine hydrochloride 1%


Medication Information

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

Purpose

Topical anagesic

Dosage and Administration

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

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

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

Description

Menthol 1% Pramoxine hydrochloride 1%

Section 51945-4

Medicated anti- itch Cream

Topical analgesic

Maximum strength pain and Itch relief

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

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

Purpose

Topical anagesic

Dosage and Administration (34068-7)

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

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

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

Section 51945-4 (51945-4)

Medicated anti- itch Cream

Topical analgesic

Maximum strength pain and Itch relief

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

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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