Curetech Gard

Curetech Gard
SPL v1
SPL
SPL Set ID 9e3def80-b173-7422-e053-2a95a90ac0b8
Route
TOPICAL
Published
Effective Date 2019-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (18 mg)
Inactive Ingredients
Glyceryl Monostearate Sodium Laureth-3 Sulfate Food Yellow 3 Free Acid Isopropyl Myristate Lavender Oil Sodium Benzoate Fd&c Yellow No. 5 Stearic Acid Aloe Vera Leaf Alpha-tocopherol Cetostearyl Alcohol Cholecalciferol Glycerin Lanolin Mineral Oil Paraffin Phenoxyethanol Vitamin A Palmitate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-11-21

Description

Zinc Oxide (1.8% w/w)

Purpose

Skin Prorectant


Medication Information

Purpose

Skin Prorectant

Description

Zinc Oxide (1.8% w/w)

Uses:
  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects Skin against irritation due to such rash and
  • Helps protect skin from exposure to wetness
Warnings:

For external use only

Directions:
  • Change wet or solied diapers promptly
  • Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
  • Allow to dry
  • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged
Active Ingredient

Zinc Oxide (1.8% w/w)

Package Labeling:

Other Information:
  • Store at room temperature 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
Inactive Ingredients:

Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, Vitamin A Palmitate, Water.

When Using This Product
  • Avoid contact with eyes
  • If eye contact occurs, flush with water
Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Center right away
Stop Use and Ask A Doctor If:
  • Condition worsens or does not improve within seven days

Structured Label Content

Uses:
  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects Skin against irritation due to such rash and
  • Helps protect skin from exposure to wetness
Purpose

Skin Prorectant

Warnings:

For external use only

Directions:
  • Change wet or solied diapers promptly
  • Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
  • Allow to dry
  • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged
Active Ingredient (Active ingredient)

Zinc Oxide (1.8% w/w)

Package Labeling:

Other Information: (Other information:)
  • Store at room temperature 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, Vitamin A Palmitate, Water.

When Using This Product (When using this product)
  • Avoid contact with eyes
  • If eye contact occurs, flush with water
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
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Condition worsens or does not improve within seven days

Advanced Ingredient Data


Raw Label Data

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