SKYLARK- zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Skylark CMC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant - Helps treat and prevent rash associated with diaper rash, incontinence or exposure to feces and urine - Protects skin against irritation due to such rash and - Helps protect skin from exposure to wetness - condition worsens or doesn't improve within seven days

Authorization status:

OTC monograph final

Summary of Product characteristics

SKYLARK- ZINC OXIDE OINTMENT
SKYLARK CMC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
_ACTIVE INGREDIENT_
Zinc Oxide 3.8%
_PURPOSE_
Skin Protectant
_USES_
Helps treat and prevent rash associated with diaper rash, incontinence
or exposure to feces and urine
Protects skin against irritation due to such rash and
Helps protect skin from exposure to wetness
_WARNINGS_
FOR EXTERNAL USE ONLY
_WHEN USING THIS PRODUCT_
Avoid contact with eyes
if eye contact occurs, flush with water
_STOP USE AND ASK A DOCTOR IF_
condition worsens or doesn't improve within seven days
_KEEP OUT OF REACH OF CHILDREN_
If swallowed get medical help or contact a Poison Control Center
rightaway
_DIRECTIONS_
Change wet or soiled diapers promptly
Clean diaper area with a mild cleanser, paying special attention to
the perineum, buttocks, lower
abdomen and inner thighs
Allow area to dry
Apply to affected area as often as necessary or with each diaper
change, especially at bedtime or
anytime when exposure to soiled diapers may be prolonged
_INACTIVE INGREDIENTS_
Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea
Mays Oil, Fragrance,
Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate
(Vitamin A), Sodium Borate,
Tocopherol Acetate (Vitamin E), Water, White Petrolatum
SKYLARK
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7116 8 -8 0 20
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
Skylark CMC
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
3.8 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)
ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)
PETRO LATUM (UNII: 4T6 H12BN9 U)
CHLO RO XYLENO L (UNII: 0 F32U78 V2Q)
CHO LECALCIFERO L (UNII: 1C6 V77QF41)
CO RN O IL (UNII: 8 470 G57WFM