COTTONTAILS DIAPER RASH- zinc oxide ointment

COTTONTAILS DIAPER RASH by

Drug Labeling and Warnings

COTTONTAILS DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by AMERICAN SALES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                     Purpose

Zinc oxide, 40% .....................................................................Skin protectant

PURPOSE

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps protect skin from wetness
  

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

over deep or puncture wounds, infections or lacerations

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if condition worsens or does not improve within 7 days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  

STORAGE AND HANDLING

Other information

• store at 20o to 25oC (68o to 77oF)
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients

BHA, cod liver oil (high in vitamin A and D), fragrance, lanolin, methylparaben, petrolatum, talc and purified water, light mineral oil, tartrazine yellow #4 (FD and C yellow #4)

DOSAGE & ADMINISTRATION

DISTRIBUTED BY: AMERICAN SALES COMPANY

4201 WALDEN AVENUE, LANCASTER, NY 14086

www.Care1.info

Made in Korea

PRINCIPAL DISPLAY PANEL

Enter section text here

INGREDIENTS AND APPEARANCE

COTTONTAILS DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-343
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.4 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
COD LIVER OIL (UNII: BBL281NWFG)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LANOLIN (UNII: 7EV65EAW6H)
TALC (UNII: 7SEV7J4R1U)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-343-40	1 in 1 CARTON
1		113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/01/2012

Labeler - AMERICAN SALES (809183973)