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TRIPLE

Summers Laboratories Inc




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENT

ZINC OXIDE 12.8%

Purpose

PURPOSE

SKIN PROTECTANT

Uses

USES

  • HELPS TREAT AND PREVENT DIAPER RASH
  • PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS

WARNINGS

FOR EXTERNAL USE ONLY

When using this product

  • DO NOT GET INTO EYES

Stop 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 CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Directions

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow skin to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Inactive ingredients

white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.

TRIPLE

TRIPLE

ZINC OXIDE PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11086-021
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 12.8 g

Inactive Ingredients

Ingredient Name Strength
petrolatum
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
LANOLIN
stearyl alcohol
YELLOW WAX
.ALPHA.-BISABOLOL, (+/-)-
CHOLESTEROL
water
GLYCERIN
OAT
polysorbate 80

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11086-021-01 56.7 in 1 TUBE
2 NDC:11086-021-05 99 in 1 TUBE
3 NDC:11086-021-03 237 in 1 JAR
4 NDC:11086-021-02 454 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2013-10-30


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