WOUND REPAIR- zinc oxide ointment
CANDICE NELMS, INC.

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.

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WOUND REPAIR

Active Ingredients

Non-nano Zinc Oxide 20%

Inactive Ingredients

Beeswax, Coconut oil, Evening Primrose oil,
Frankincense essential oil, Golden Jojoba oil,
Lavender essential oil, Rose Geranium
essential oil, Tamanu oil, Tea Tree essential oil

Purpose

Active Ingredients-----------------Purpose

Non-nano Zinc Oxide 20%.......Skin protectant

Keep Out of Reach of Children

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center.

Uses*

■ Temporarily protects minor cuts, scrapes, burns
■ Promotes the healing process of the skin

Warnings

For external use only. Avoid Eyes.

Directions

Apply generously to open wound or burn and cover 4-6 hours. Remove bandage, clean and repeat until skin is restored. For mature scarring or severely dry skin, use like lotion with thin application and rub into affected areas.

Do Not Use

Do not use if tamper evident seal is broken.

first aid ointment promotes the healing process of the skin
.

THE ALCHEMIST COLLECTION
175 Wrenn St.
Tavernier. FL 33070
www.thealchemistcollection.com

Stop use and ask doctor

Stop use and ask doctor if ■ condition worsens,
■ symptoms last more than 7 days.

Box Tibe

WOUND REPAIR
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71281-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
TAMANU OIL (UNII: JT3LVK84A1)
JOJOBA OIL (UNII: 724GKU717M)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
YELLOW WAX (UNII: 2ZA36H0S2V)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71281-201-05	1 in 1 BOX	06/13/2018
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/13/2018	07/01/2019

Labeler - CANDICE NELMS, INC. (080545348)

Name	Address	ID/FEI	Business Operations
Establishment
CANDICE NELMS, INC.		080545348	manufacture(71281-201)

Revised: 7/2021

Document Id: c794fbe5-8eff-622b-e053-2995a90a83b8

Set id: 7dfb419a-8724-9842-e053-2991aa0ab6f1

Version: 4

Effective Time: 20210720

CANDICE NELMS, INC.