AMERIDERM PERISHIELD- zinc oxide ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Shield Line LLC
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
Authorization number:
52410-8020-0, 52410-8020-4

AMERIDERM PERISHIELD- zinc oxide ointment

Shield Line LLC

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.

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PeriShield

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 right away.

Directions

■ Change wet and 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, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol,

Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6,

Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax,

Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin

A Palmitate, Water

Package Label

AMERIDERM PERISHIELD

zinc oxide ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:52410 -8 0 20

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ZINC OXIDE

3.8 g in 10 0 g

Inactive Ingredients

Shield Line LLC

Ingredient Name

Stre ng th

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CHLO RO XYLENO L (UNII: 0 F32U78 V2Q)

CHO LECALCIFERO L (UNII: 1C6 V77QF41)

CO RN O IL (UNII: 8 470 G57WFM)

LANO LIN (UNII: 7EV6 5EAW6 H)

MINERAL O IL (UNII: T5L8 T28 FGP)

PARAFFIN (UNII: I9 O0 E3H2ZE)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

SO DIUM LAURETH-3 SULFATE (UNII: BPV39 0 UAP0 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:52410 -8 0 20 -4

452 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 15

2

NDC:52410 -8 0 20 -0

10 0 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 1/0 1/20 15

Labeler -

Shield Line LLC (078518916)

Revised: 2/2020

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