Natures Choice Vitamins A and D: Package Insert and Label Information

NATURES CHOICE VITAMINS A AND D- petrolatum ointment
Unipack, 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.

Active Ingredient

White Petrolatum 98.3%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes, and burns

Temporarily protects and helps relieve chapped or cracked skin

Helps treat and prevent diaper rash caused from wetness, urine, and/or stool

Warnings

For external use only

Do not use on

deep or puncture wounds, animal bites, serious burns, an area that is infected

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens

symptoms last for more than 7 days or clear up and occur 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

Gently cleanse and pat dry affected area.

Apply as needed.

Other information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aloe extract, Benzethonium Chloride, Cholecalciferol (Vitamin D), Cococaprylate/Caprate, Corn Oil, Retinyl, Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E)

Warning:

Keep out of reach of children.

In case of emergency or accidental ingestion seek professional assistance or contact a Poison Control Center immediately.

Directions:

Apply to affected area of skin.

Use liberally.

May be covered with bandage or dressing or use as directed by physician

Store

Store at room temperature.

For external use only.

Do not use in the eye.

Label

NATURES CHOICE VITAMINS A AND D a and d ointment ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-330 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (PETROLATUM) PETROLATUM 98.3 g in 100 g

Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE .002 g in 100 g CHOLECALCIFEROL .001 g in 100 g ALOE VERA LEAF .5 g in 100 g .ALPHA.-TOCOPHEROL ACETATE, DL- .1 g in 100 g COCO-CAPRYLATE/CAPRATE .993 in 100 g BENZETHONIUM CHLORIDE .004 in 100 g CORN OIL .1 in 100 g

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43749-330-16 453 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/18/2014

Labeler — Unipack, Inc. (009248480)

Establishment
Name	Address	ID/FEI	Operations
Unipack, Inc.		009248480	manufacture (43749-330)

Revised: 06/2018 Unipack, Inc.