SPL v3
SPL
SPL Set ID 21a7c4ce-1360-931c-e063-6294a90aa66d
Route
TOPICAL
Published
Effective Date 2024-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (40 g)
Inactive Ingredients
Isopropyl Myristate Aloe Vera Leaf Yellow Wax Petrolatum Mineral Oil .alpha.-tocopherol Acetate Lanolin Cod Liver Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-03

Description

Zinc Oxide(40%)


Medication Information

Warnings and Precautions



For external use only

Description

Zinc Oxide(40%)

Use



helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps seal out wetness

Section 50565-1



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

Section 50567-7



When using this product do not get into eyes.

Section 51945-4

Section 55105-1



Skin Protectant

Section 55106-9



Zinc Oxide(40%)

Directions

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply cream liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers will be prlonged

Other Information

store at 68° to 77° F (20° to 25°C)

do not use if tube seal under cap is broken or missing

Inactive Ingredients

Petrolatum

Mineral Oil

Lanolin

Isopropyl Myristate

Beeswax

Tocopheryl Acetate

Cod Liver Oil

Aloe Barbadensis Leaf Juice

Stop Use and Ask A Doctor If



condition worsens

symptoms last more than 7 days or clear up and occur again with a few days.


Structured Label Content

Use



helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps seal out wetness

Warnings and Precautions (34071-1)



For external use only

Section 50565-1 (50565-1)



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

Section 50567-7 (50567-7)



When using this product do not get into eyes.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Skin Protectant

Section 55106-9 (55106-9)



Zinc Oxide(40%)

Directions

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply cream liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers will be prlonged

Other Information (Other information)

store at 68° to 77° F (20° to 25°C)

do not use if tube seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

Petrolatum

Mineral Oil

Lanolin

Isopropyl Myristate

Beeswax

Tocopheryl Acetate

Cod Liver Oil

Aloe Barbadensis Leaf Juice

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)



condition worsens

symptoms last more than 7 days or clear up and occur again with a few days.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)