Little onesmaximum strength cream

Otc - active ingredient section

Active Ingredient

Zinc Oxide 40 %

Otc - purpose section

Purpose

Skin protectant

Indications & usage section

Uses

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

Otc - keep out of reach of children section

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

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

Dosage & administration section

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

Storage and handling section

Other information

  • store between 20- 25C (68-77F)

Inactive ingredient section

Inactive ingredientsbutylated hydroxyanisole, cod liver oil

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

petrolatum, purifeid water, talc

Warnings section

Warning s

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


Ingredients and appearance - Product information

Little onesmaximum strength cream- Zinc oxide

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 40 gin 100 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA

Labeler - Kmart Corporation( 008965873)

Package label.principal display panel