DIAPER RASH- zinc oxide cream

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

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Valu Merchandisers, Co.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash - helps seal out wetness
Authorization status:
OTC monograph final
Authorization number:
63941-318-04

DIAPER RASH- zinc oxide cream

Valu Merchandisers, Co.

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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Drug Facts

Active ingredient

Zinc Oxide 40%

Purpos e

Skin Protectant

Us es

helps treat and prevent diaper rash

protects chafed skin due to diaper rash

helps seal out wetness

Warnings

For external and/or intrarectal 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 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

clean the diaper area

allow to dry

apply cream liberally as often as necessary, with each diaper change, especially at bedtime or

anytime exposure to wet diapers may be prolonged

Other information

store at 20 to 25C (68 to 77F)

Inactive ingredients

butylated hydroxytoluene, cod liver oil, fd&c yellow #4, lanolin, methyl paraben, paraffin wax, purified

water, talc powder, white petrolatum

Questions or comments?

Call toll free: 1-800-883-0085

Package label

Diaper Rash Cream

DIAPER RASH

zinc oxide cream

Product Information

Valu Merchandisers, Co.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 41-318

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

40 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

CO D LIVER O IL (UNII: BBL28 1NWFG)

LANO LIN (UNII: 7EV6 5EAW6 H)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PETRO LATUM (UNII: 4T6 H12BN9 U)

TALC (UNII: 7SEV7J4R1U)

WATER (UNII: 0 59 QF0 KO0 R)

PARAFFIN (UNII: I9 O0 E3H2ZE)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 39 41-318 -0 4

1 in 1 BOX

0 1/30 /20 12

1

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

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 1/30 /20 12

Labeler -

Valu Merchandisers, Co. (868703513)

Revised: 3/2019

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