Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a90049e4-27a5-447c-8d3d-c319c3c7baf7
Route
TOPICAL
Published
Effective Date 2017-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g) Zinc Cation (.1 g)
Inactive Ingredients
Alcohol Oatmeal Camphor (synthetic) Citric Acid Monohydrate Diazolidinyl Urea Glycerin Hypromellose, Unspecified Methylparaben Polysorbate 40 Propylene Glycol Propylparaben Sodium Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-10-31

Description

Pramoxine  HCl 1% Zinc Acetate 0.1%

Purpose

Itch Relief.


Medication Information

Purpose

Itch Relief.

Description

Pramoxine  HCl 1% Zinc Acetate 0.1%

Section 51945-4

CVS Continuous Spray Itch Relief

Clear Skin Protectant

1% Pramoxine HCl

0.1% Zinc Acetate

uses
  • Temporarily relieves pain and itching asociated with:
  • rashes due to poison ivy, poison oak or poison sumac.
  • insect bites.
  • minor skin irritation.
  • minor cuts.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Directions
  • shake well before use.
  • 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: ask a doctor. 
purpose

Itch Relief.

warnings

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

​​​

active Ingredient

Pramoxine  HCl 1%

Zinc Acetate 0.1%

inactive Ingredients

SD Alcohol 38-B, Avena Sative (Oat Meal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hypromellose, Methylparaben,Polysorbate 40, Propylene Glycol, Propylparaben, Sodium Citrate, Water.

when Using This Product
  • keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

stop Use and Ask A Doctor If
  • condition worsens or does not improve within 7 days.
  • symptoms persist for more than 7 days or clear up and occur again with in a few days.

keep Out of Reach of Children

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


Structured Label Content

Section 51945-4 (51945-4)

CVS Continuous Spray Itch Relief

Clear Skin Protectant

1% Pramoxine HCl

0.1% Zinc Acetate

uses (Uses)
  • Temporarily relieves pain and itching asociated with:
  • rashes due to poison ivy, poison oak or poison sumac.
  • insect bites.
  • minor skin irritation.
  • minor cuts.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Directions
  • shake well before use.
  • 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: ask a doctor. 
purpose (Purpose)

Itch Relief.

warnings (Warnings)

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

​​​

active Ingredient (Active ingredient)

Pramoxine  HCl 1%

Zinc Acetate 0.1%

inactive Ingredients (Inactive ingredients)

SD Alcohol 38-B, Avena Sative (Oat Meal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hypromellose, Methylparaben,Polysorbate 40, Propylene Glycol, Propylparaben, Sodium Citrate, Water.

when Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve within 7 days.
  • symptoms persist for more than 7 days or clear up and occur again with in 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 right away.


Advanced Ingredient Data


Raw Label Data

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