Drug Facts 62654-145

Drug Facts 62654-145
SPL v5
SPL
SPL Set ID 48eb2031-bc80-45d5-b8b3-cc08fcab64f1
Route
TOPICAL
Published
Effective Date 2011-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Water Polyglyceryl-4 Isostearate Hexyl Laurate Mineral Oil Isopropyl Palmitate Ethylhexyl Palmitate Theobroma Grandiflorum Seed Glycerin Dimethicone Sodium Chloride Diazolidinyl Urea Menthol Hydrogenated Castor Oil Yellow Wax Tocopherol Methylparaben Corn Oil Vitamin A Palmitate Cholecalciferol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-01

Description

Active Ingredients Zinc Oxide 20% (w/w)


Medication Information

Warnings and Precautions

Warnings

For External Use Only

Indications and Usage

Uses

Helps treat and prevent diaper rash

Protects minor skin irritation due to diaper rash and helps seal out wetness

Dosage and Administration

Directions

For Diaper Rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

For Skin Protection: Apply liberally as needed.

Description

Active Ingredients Zinc Oxide 20% (w/w)

Section 44425-7

Other Information

Protect from freezing.

Avoid excessive heat

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 50570-1

Do not use

on deep or puncture wounds

on animal bites

on serious burns

Section 51727-6

Inactive Ingredients

Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)

Section 51945-4

BOA

VIDA

Calvida

protectant shield

helps treat minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active Ingredients

Zinc Oxide 20% (w/w)


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps treat and prevent diaper rash

Protects minor skin irritation due to diaper rash and helps seal out wetness

Dosage and Administration (34068-7)

Directions

For Diaper Rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

For Skin Protection: Apply liberally as needed.

Warnings and Precautions (34071-1)

Warnings

For External Use Only

Section 44425-7 (44425-7)

Other Information

Protect from freezing.

Avoid excessive heat

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 50570-1 (50570-1)

Do not use

on deep or puncture wounds

on animal bites

on serious burns

Section 51727-6 (51727-6)

Inactive Ingredients

Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)

Section 51945-4 (51945-4)

BOA

VIDA

Calvida

protectant shield

helps treat minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Zinc Oxide 20% (w/w)


Advanced Ingredient Data


Raw Label Data

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