SPL v3
SPL
SPL Set ID 0bdf463c-2139-9376-e063-6394a90a33ea
Route
TOPICAL
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Cetyl Alcohol Benzyl Alcohol Dehydroacetic Acid White Petrolatum Ceramide Ap Subtilisin Lactic Acid Caprylyl Glycol Sodium Chloride Polyglyceryl-3 Diisostearate .alpha.-glucan Oligosaccharide Water Cholesterol Xanthan Gum Lanolin Inulin Phytosphingosine Carbomer Homopolymer, Unspecified Type Ceramide 1 Limosilactobacillus Fermentum Ethylhexylglycerin White Wax Starch, Corn Tridecyl Trimellitate Glycerin Polyglyceryl-2 Dipolyhydroxystearate Sodium Lauroyl Lactylate Ceramide Np Honey

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-07

Description

Zinc Oxide 20%

Purpose

Zinc oxide 20%...................Skin Protectant


Medication Information

Purpose

Zinc oxide 20%...................Skin Protectant

Description

Zinc Oxide 20%

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
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
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product

  • do not get into eyes
Section 51945-4

Bottom Buddy

buddle

Diaper Cream

Prevent diaper rash

Nourish baby's skin and normalize pH

ZINC OXIDE SKIN PROTECTANT

PROTECT

NET WT 4 OZ (113 g)

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Questions?

Call 833-777-6880

Active Ingredient

Zinc Oxide 20%

Other Information
  • store at 20°C to 25°C (68°F to77°F)
  • may stain clothing
Inactive Ingredients

white petrolatum, water, anhydrous lanolin, zea mays (corn) starch, tridecyl trimellitate, glycerin, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, beeswax white, ceramide AP, ceramide NP, ceramide EOP, honey, alpha-glucan oligosaccharide, lactobacillus ferment, subtilisin, inulin, phytosphingosine, cetyI alcohol, lactic acid, xanthan gum, ethylhexylglycerin, benzyl alcohol, caprylyl glycol, carbomer, dehydroacetic acid, sodium chloride, sodium lauroyl lactylate, cholesterol


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
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
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • do not get into eyes
Section 51945-4 (51945-4)

Bottom Buddy

buddle

Diaper Cream

Prevent diaper rash

Nourish baby's skin and normalize pH

ZINC OXIDE SKIN PROTECTANT

PROTECT

NET WT 4 OZ (113 g)

Purpose

Zinc oxide 20%...................Skin Protectant

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Questions?

Call 833-777-6880

Active Ingredient

Zinc Oxide 20%

Other Information
  • store at 20°C to 25°C (68°F to77°F)
  • may stain clothing
Inactive Ingredients

white petrolatum, water, anhydrous lanolin, zea mays (corn) starch, tridecyl trimellitate, glycerin, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, beeswax white, ceramide AP, ceramide NP, ceramide EOP, honey, alpha-glucan oligosaccharide, lactobacillus ferment, subtilisin, inulin, phytosphingosine, cetyI alcohol, lactic acid, xanthan gum, ethylhexylglycerin, benzyl alcohol, caprylyl glycol, carbomer, dehydroacetic acid, sodium chloride, sodium lauroyl lactylate, cholesterol


Advanced Ingredient Data


Raw Label Data

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