OTC Medication Information: Zinc Oxide

ZINC OXIDE- zinc oxide spray, suspension
Kindred Bravely

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Zinc Oxicd 25%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects minor skin irritation associated with diaper rash
Helps seal out wetness

Warnings

For external use only

When using this product

avoid contact with eyes

Stop use and ask a doctor

if symptoms last more than 7 days or clears up and occurs again within a few days.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Shake well before use
Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
Spray 4-6 inches away from skin.
Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
No need to rub in.

Inactive Ingredients

Aqua (Water), Helianthus annuus (Sunflower) Oil, Simmondsia chinensis (Jojoba) Seed Oil, Ricinus communis (Castor) Seed Oil, Butyrospermum parkii (Shea) Butter, Cetearyl Alcohol, Cetearyl Glucoside, Organic Aloe barbadensis (Aloe vera) Leaf Juice, Glyceryl Caprylate, Caprylhydroxamic Acid, Xanthan Gum.

Distributed by Sensible

3913 Oceanic Drive, Suite 502

Oceanside, CA 92056

888-850-3756

www.kindredbravely.com

ZINC OXIDE zinc oxide spray, suspension

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82751-103 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 250 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CASTOR OIL SHEA BUTTER CETEARYL GLUCOSIDE GLYCERYL CAPRYLATE WATER O-18 SUNFLOWER OIL CAPRYLHYDROXAMIC ACID XANTHAN GUM JOJOBA OIL CETOSTEARYL ALCOHOL ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82751-103-01 89 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/14/2022

Labeler — Kindred Bravely (085227654)

Establishment
Name	Address	ID/FEI	Operations
Royal Labs Natural Cosmetics		197478480	manufacture (82751-103)

Revised: 05/2022 Kindred Bravely