diaper rash cream happy cheeks 02-ap-123

diaper rash cream happy cheeks 02-ap-123
SPL v3
SPL
SPL Set ID 26cef2eb-a133-11ec-e063-6394a90a0f08
Route
topical
Published
Effective Date 2024-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (14.9 g)
Inactive Ingredients
glyceryl oleate water butyrospermum parkii (shea) butter glycerin microcrystalline cellulose olea europaea (olive) fruit oil cellulose gum cetearyl alcohol ricinus communis (castor) seed oil propanediol bentonite caprylhydroxamic acid coco-glucoside glyceryl rosinate olea europaea (olive) oil unsaponifiables aloe barbadensis leaf juice caprylyl glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-13

Description

Zinc Oxide 14.9%


Medication Information

Warnings and Precautions

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

Active Ingredient

Zinc Oxide 14.9%

Uses

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

Dosage and Administration

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

Description

Zinc Oxide 14.9%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center immediately

Section 51727-6

Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Coco Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water

Section 51945-4

Section 53413-1

212-627-0377 M-F 9am to 5pm EST

Section 55105-1

Skin Protectorant

Section 60561-8

Protect this product from excessive heat and direct sun • May stain some fabrics and surfaces


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

Zinc Oxide 14.9%

Uses

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

Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center immediately

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Coco Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

212-627-0377 M-F 9am to 5pm EST

Section 55105-1 (55105-1)

Skin Protectorant

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun • May stain some fabrics and surfaces


Advanced Ingredient Data


Raw Label Data

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