Extra Strength Itch Stopping Cream

Extra Strength Itch Stopping Cream
SPL v3
SPL
SPL Set ID b9a42aa3-1903-76f0-e053-2a95a90a51d1
Route
TOPICAL
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg) Zinc Cation (1 mg)
Inactive Ingredients
Propylparaben Water Potassium Hydroxide Cetyl Alcohol Diazolidinyl Urea Methylparaben Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-21

Description

temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac


Medication Information

Description

temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Uses
  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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 within a few days
Section 50567-7

When using this product avoid contact with eyes

Section 50569-3

Ask a doctor before use

  • on chicken pox
  • on measles
Section 50570-1

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Section 55105-1
Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Warnings

For external use only

Directions
  • do not use more than directed
  • 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
Questions?

Call toll-free 1-800-222-1222

Other Information
  • protect from excessive heat (40°C/104°F)
Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Principal Display Panel 35.4 G Tube Carton

EXTRA STRENGTH

Topical Analgesic/Skin Protectant

ITCH



STOPPING



CREAM

NET WT 1.25 OZ (35.4 g)


Structured Label Content

Uses
  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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 within a few days
Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50569-3 (50569-3)

Ask a doctor before use

  • on chicken pox
  • on measles
Section 50570-1 (50570-1)

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Section 55105-1 (55105-1)
Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Warnings

For external use only

Directions
  • do not use more than directed
  • 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
Questions?

Call toll-free 1-800-222-1222

Other Information (Other information)
  • protect from excessive heat (40°C/104°F)
Inactive Ingredients (Inactive ingredients)

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Principal Display Panel 35.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton)

EXTRA STRENGTH

Topical Analgesic/Skin Protectant

ITCH



STOPPING



CREAM

NET WT 1.25 OZ (35.4 g)


Advanced Ingredient Data


Raw Label Data

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