Qc Poison Ivy Wash

Qc Poison Ivy Wash
SPL v4
SPL
SPL Set ID 873a546b-90ae-50cb-e053-2a91aa0adbfb
Route
TOPICAL
Published
Effective Date 2019-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Glycol Distearate Propylene Glycol Diazolidinyl Urea Methylparaben Water Ammonium Lauryl Sulfate Hydrolyzed Jojoba Esters (acid Form) Edetic Acid Nonoxynol-9 Propylparaben Glycerin Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-24

Description

Pramoxine HCl 1%


Medication Information

Warnings and Precautions

For external use only.

When using this product:

Avoid Contact with eyes.

Do not leave on skin longer than 3 minutes

Rinse thoroughly after application

Indications and Usage

For temporary relief of pain and itching associated with poison ivy, poison oak, and poison sumac.

Dosage and Administration

Adults and children 2 years of age and older: wet the affected area, apply product to affected skin and surrounding area. work foam into lather and rub for up to 3 minutes if needed. do not leave on skin for longer than 3 minutes. Thoroughly rinse product form all areas. Apply to affected are not more than 3 to 4 times daily.

Description

Pramoxine HCl 1%

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Section 50567-7

When using this product avoid contact with the eyes. Do not leave on skin longer than 3 minutes. Rinse thoroughly after application.

Section 50569-3

Stop use and ask a doctor if condition worses, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51727-6

Water

ammonium lauryl sulfare

distearyl phtalic acid amide

glycol distereate

cocamide MIPA

Propylene glycol

Diazolidyn Urea

Methylparaben

Propylparaben

Glycerin

Jojoba esters

disodium edta

sodium hydroxide

nonoxynol-9

Section 51945-4

Section 55105-1

External Analgesic

Section 55106-9

Pramoxine HCl 1%


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of pain and itching associated with poison ivy, poison oak, and poison sumac.

Dosage and Administration (34068-7)

Adults and children 2 years of age and older: wet the affected area, apply product to affected skin and surrounding area. work foam into lather and rub for up to 3 minutes if needed. do not leave on skin for longer than 3 minutes. Thoroughly rinse product form all areas. Apply to affected are not more than 3 to 4 times daily.

Warnings and Precautions (34071-1)

For external use only.

When using this product:

Avoid Contact with eyes.

Do not leave on skin longer than 3 minutes

Rinse thoroughly after application

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes. Do not leave on skin longer than 3 minutes. Rinse thoroughly after application.

Section 50569-3 (50569-3)

Stop use and ask a doctor if condition worses, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51727-6 (51727-6)

Water

ammonium lauryl sulfare

distearyl phtalic acid amide

glycol distereate

cocamide MIPA

Propylene glycol

Diazolidyn Urea

Methylparaben

Propylparaben

Glycerin

Jojoba esters

disodium edta

sodium hydroxide

nonoxynol-9

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)

Pramoxine HCl 1%


Advanced Ingredient Data


Raw Label Data

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