Diaper Rash Cream /

Diaper CreamCCRR, FDA

Legal Mandates

Republic Act No. 9711

“The FDA Act of 2009”

Drugs refers to 1. Articles recognized in official pharmacopeias and

formularies, including official homeopathicpharmacopeias, or any documentary supplement to any ofthem, which are recognized and adopted by the FDA;

2. Articles intended for use in the diagnosis, cure, mitigation,treatment, or prevention of disease in man or otheranimals;

3. Articles (other than food) intended to affect the structure ofany function of the body of humans or animals; or

4. Articles intended for use as a component of any articlesspecificed in clauses (1), (2), or (3) but do not includedevices or their components, parts or accessories

Household Remedies (as per AO 117 s 1992)

“any preparation containing pharmaceutical

substances of common or ordinary use to relieve

common physical ailments which may be

dispensed without a medical prescription in

original packages, bottles or containers, the

nomenclature of which has been duly approved

by BFAD in the process of registration”

Cosmetic refers to(as per ASEAN Cosmetic Directive)

“any substance or preparation to be placed in contact with

various external parts of the human body (epidermis, hair

system, nails, lips, and external genital organ) or with the teeth

and mucous membranes of the oral cavity with a view

exclusively or mainly to cleaning them, perfuming them,

changing their appearance and/or, correcting body odors

and/or, protecting them or, keeping them in good condition.

ACD Appendix III – ASEAN Cosmetic Claim Guideline

further states that a cosmetic product should not be presented

as treating or preventing disease in human beings.

Disease• an illness that affects a person

• a condition that prevents the body or mind from

working normally

• a condition of the living animal or plant body or of

one of its parts that impairs normal functioning

and is typically manifested by distinguishing signs

and symptoms

Diaper Rash

• a common form of inflamed skin (dermatitis) that appears as a patchwork of bright red skin on your baby's bottom (Mayo Clinic)

• a skin problem that develops in the area beneath an infant's diaper. (U.S. National Library of Medicine)

• results from prolonged or extended contact of the skin with urine, feces, moisture or friction

• also known as diaper dermatitis, napkin dermatitis, napkin rash, and nappy rash

Causes of Diaper Rash

• may be caused by infection with a yeast (fungus) called Candida.

• acids in the stool (seen more often when the child has diarrhea)

• ammonia (a chemical produced when bacteria break down urine)

• diapers that are too tight or rub the skin

• reactions to soaps and other products used to clean cloth diapers

Symptoms

• bright red rash that gets bigger

• very red and scaly areas on the scrotum and penis in boys

• red or scaly areas on the labia and vagina in girls

• pimples, blisters, ulcers, large bumps, or sores filled with pus

• smaller red patches (called satellite lesions) that grow and blend in with the other patches

Prevention and Treatment• Includes ointment / cream / lotion / powder

containing ZINC OXIDE which forms an

occlusive barrier between the infant’s skin

and the likely cause of the diaper rash

ZINC OXIDECOSMETIC

• Zinc Oxide is only allowed to be used as a UV filter as per ACD Annex VII - List Of UV Filters Which Cosmetic Products May Contain

DRUG

• Zinc Oxide is included in Annex A of AO 117 s 1992

Reference No. Substance Limit

A29 Zinc oxide 25 %

Conclusion

Diaper Rash Creams / Lotions / Ointments and the like are therefore classified as a HOUSEHOLD REMEDIES under the Center for Drug Regulation and Research.

THANK YOU.