COTTONTAILS DIAPER RASH - zinc oxide ointment 
AMERICAN SALES

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                                                                     Purpose

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

Uses

Warnings

For external use only

Do not use

over deep or puncture wounds, infections or lacerations

When using this product avoid contact with the eyes

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

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

Directions

Other information

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)

DISTRIBUTED BY: AMERICAN SALES COMPANY

4201 WALDEN AVENUE, LANCASTER, NY 14086

www.Care1.info

Made in Korea

image of carton labelEnter section text here

COTTONTAILS DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-343
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.4 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-343-401 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2012
Labeler - AMERICAN SALES (809183973)

Revised: 5/2012
Document Id: d7d1e9e7-2bcc-4e74-9007-80d9fb3adee2
Set id: 9e55a124-7f42-4c05-8834-7eb8e33ab8d9
Version: 1
Effective Time: 20120501
 
AMERICAN SALES