Active Ingredients
Dimethicone 1%
Zinc Oxide 10%
Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide
FDA Label NDC 65197-402
14 label sections · Submitted to the FDA by Wellspring Pharmaceutical Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide (NDC 65197-402). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Diaper Rash Cream
Diaper Rash Cream
Uses
- helps treat and prevent diaper rash
- protects minor skin irritation due to diaper rash and helps seal out wetness
Warnings
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
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area, and allow to dry
- apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
- aloe barbadensis leaf extract, benzyl alcohol, cocos nucifera (coconut) oil, cod liver oil (contains vitamin A & vitamin D), fragrance, glyceryl monooleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water
Questions?
1-844-241-5454
Distributed By:
WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
© 2023 WellSpring Pharmaceutical Corporation
www.ADskinhealth.com
Package Label. Principal Display Panel
Treat & Heal Cream Diaper Rash Zinc Cream
FAST-ACTING, MOISTURIZING ZINC FORMULA
With Vitamins A+D
plu
Aloe Vera
Allows skin to heal naturally
Calms diaper rash on contact
NET WT 4 OZ (113g)
A+d Treat Diaper Rash Cream 4oz. (IFC)
A+D Treat Zinc Ointment 454G.
NET WT1 LB (454g)
Ad Treat Diaper Rash Cream 1 Lb (Ad Treat Diaper Rash Cream With Dimethicone And Zi 2)
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