Astonea Medicated Body Powder

Astonea Medicated Body Powder
SPL v2
SPL
SPL Set ID e69b4924-313b-0ea5-e053-2995a90a616d
Route
TOPICAL
Published
Effective Date 2021-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.15 g) Zinc Oxide (1 g)
Inactive Ingredients
Sodium Bicarbonate Starch, Corn Gum Talha Eucalyptol Methyl Salicylate Salicylic Acid Thymol Zinc Stearate Tricalcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-05

Description

Menthol 0.15 % Zinc Oxide 1.0%

Purpose

Anti-itch Skin Protectant


Medication Information

Purpose

Anti-itch

Skin Protectant

Description

Menthol 0.15 % Zinc Oxide 1.0%

Uses

for the temporary relief of the pain and itch associated with

  • minor cuts
  • scrapes
  • sunburn
  • insect bites
  • prickly heat
  • rashes
  • minor burns
  • minor skin irritations
  • dries the oozing of poison ivy, oak and sumac.

Section 51945-4

Warnings

For external use only

Directions
  • adults and children 2 years and older, apply freely up to 3 or 4 times daily
  • under 2 years: ask a doctor before using
  • for best results, dry skin thoroughly before use
Drug Facts

Menthol 0.15 %

Zinc Oxide 1.0%

Inactive Ingredients

Corn Starch, Eucalyptol, Gum Talha, Methyl Salicylate, Salicylic Acid, Sodium Bicarbonate, Thymol, Tricalcium Phosphate, Zinc Stearate

When Usin This Product
  • Avoid contact with eyes.
  • Keep away from face and mouth to avoid inhalation
  • Not for genital area.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms do not get better within 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

Keep out of reach of children. In case of accidential ingestion, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

for the temporary relief of the pain and itch associated with

  • minor cuts
  • scrapes
  • sunburn
  • insect bites
  • prickly heat
  • rashes
  • minor burns
  • minor skin irritations
  • dries the oozing of poison ivy, oak and sumac.

Section 51945-4 (51945-4)

Purpose

Anti-itch

Skin Protectant

Warnings

For external use only

Directions
  • adults and children 2 years and older, apply freely up to 3 or 4 times daily
  • under 2 years: ask a doctor before using
  • for best results, dry skin thoroughly before use
Drug Facts

Menthol 0.15 %

Zinc Oxide 1.0%

Inactive Ingredients

Corn Starch, Eucalyptol, Gum Talha, Methyl Salicylate, Salicylic Acid, Sodium Bicarbonate, Thymol, Tricalcium Phosphate, Zinc Stearate

When Usin This Product (When usin this product)
  • Avoid contact with eyes.
  • Keep away from face and mouth to avoid inhalation
  • Not for genital area.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms do not get better within 7 days or clear up and occur again within a few days
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of accidential ingestion, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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