HYLANDS NATURALS DIAPER RASH CREAM- zinc oxide cream

Hylands Naturals Diaper Rash Cream by

Drug Labeling and Warnings

Hylands Naturals Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Hylands, Raining Rose, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients Purpose
Zinc Oxide 10%.................................... skin protectant

PURPOSE

Purpose
Skin protectant

INDICATIONS & USAGE

Uses
■ Helps treat and prevent diaper rash.
■ Protects chafed skin associated with diaper rash
   and helps protect from wetness.

WARNINGS

Warnings
For external use only.
When using this product do not get into eyes.
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.

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

Inactive ingredients
Organic Aloe (Aloe Barbadensis) Leaf Extract,
Organic Beeswax, Organic Calendula Officinalis
Flower Extract, Organic Castor (Ricinus Communis)
Seed Oil, Organic Matricaria (Chamomilla Recutita)
Flower Extract, Organic Sunflower (Helianthus
Annuus) Seed Oil, Tocopherol.

QUESTIONS

Questions? www.hylands.com
or care@hylands.com

Package Labeling

Hylands

NATURALS

baby

DIAPER
RASH
CREAM
Helps Soothe,
Treat and Prevent
Diaper Rash
PEDIATRICIAN
TESTED

DO NOT USE IF TAMPER-EVIDENT SEAL
IS BROKEN OR MISSING.

Manufactured for:
Hyland’s, Inc.
Los Angeles, CA 90061
www.hylands.com
Certified Organic
by Oregon Tilth

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INGREDIENTS AND APPEARANCE

HYLANDS NATURALS DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WHITE WAX (UNII: 7G1J5DA97F)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CASTOR OIL (UNII: D5340Y2I9G)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4101-1	1 in 1 BOX	12/05/2022
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/05/2022

Labeler - Hylands (008316655)