Little Ones by Kmart Corporation Drug Facts

Little Ones by

Drug Labeling and Warnings

Little Ones by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LITTLE ONES MAXIMUM STRENGTH- zinc oxide cream 
Kmart Corporation

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 %

Purpose

Skin protectant

    Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness
  

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away 1-800-222-1222

Directions

• change wet and soiled diapers promptly
• cleanse the diaper area
• allow to dry

• apply paste liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged
  

Other information

• store between 20- 25C (68-77F)
  

Inactive ingredients butylated hydroxyanisole, cod liver oil

(contains vitamin A and vitamin D), fragrance, lanolin, methylparaben,

petrolatum, purifeid water, talc

Warnings

For external 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 again

within a few days

LITTLE ONES  MAXIMUM STRENGTH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-994
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
COD LIVER OIL (UNII: BBL281NWFG)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-994-15	10 in 1 CARTON	03/12/2015	12/31/2016
1		3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/12/2015	12/31/2016

Labeler - Kmart Corporation (008965873)

Revised: 1/2020

Document Id: 9bca0296-3c39-4751-e053-2995a90a95da

34390-5

Set id: f69d762a-870d-4f53-ab5f-fb5d665242af

Version: 3

Effective Time: 20200110

 

Kmart Corporation