Pipette Diaper Rash Cream

Pipette Diaper Rash by

Drug Labeling and Warnings

Pipette Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Amyris, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PIPETTE DIAPER RASH- zinc oxide cream 
Amyris, Inc

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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Pipette Diaper Rash Cream

Active Ingredients

  Zinc Oxide 14%

Purpose

Ski Protectant

Uses

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

Warnings

• For external use only

When using this product

• do not get into eyes

Stop use and aks a doctor if

•   condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•   Change wet and soiled diapers promptly
• cleanse the diaper area
• allow to dry
• apply cream liberally as often as necessary, with each diaper change, and especially at betime or any time when exposure to wet diapers may be prolonged.

Other information

Protect this product from excessive heat and direct sunlight

Inactive Ingredients

Glycerin, Squalane, Butyrospermum Parkii (Shea ) Butter, Jojoba Esters, Euterpe Oleracea Sterols,
Polyglyceryl-2 Dipolyhydroxystearate, Sorbitan Olivate, 1,2-Hexandiol, Caprylyl Glycol, Bisabolol, Linoleic Acid, Oleic
Acid, Linolenic Acid, Tocopherol.

PIPETTE DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73517-427
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SORBITAN OLIVATE (UNII: MDL271E3GR)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
OLEIC ACID (UNII: 2UMI9U37CP)
LINOLENIC ACID (UNII: 0RBV727H71)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73517-427-02	1 in 1 CARTON	02/01/2021
1	NDC: 73517-427-01	88.7 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73517-427-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	02/01/2021

Labeler - Amyris, Inc (185930182)

Revised: 11/2022

Document Id: ec977a5f-7f93-2ccd-e053-2a95a90aa6fc

34390-5

Set id: ef5ea6f5-0126-47de-9bee-9070c5f6112b

Version: 6

Effective Time: 20221103