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NDC 73517-0001-06 Pipette Eczema 10 mg/mL Details

Pipette Eczema 10 mg/mL

Pipette Eczema is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Amyris, Inc. The primary component is OATMEAL.

Product Information

NDC	73517-0001
Product ID	73517-001_e0c3c0da-7d86-12e2-e053-2a95a90afbe2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Pipette Eczema
Proprietary Name Suffix	n/a
Non-Proprietary Name	OATMEAL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	OATMEAL
Labeler Name	Amyris, Inc
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73517-0001-06 (73517000106)

Pricing Information	N/A
NDC Package Code	73517-001-06
Billing NDC	73517000106
Package	1 BOTTLE in 1 BOX (73517-001-06) / 177 mL in 1 BOTTLE
Marketing Start Date	2022-05-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5c5c81cd-6763-4c80-b1c6-89bbac703a8c Details

Drug Facts

Active Ingredients

Colloidal Oatmeal 1 %

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

• eczema • rashes

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

Keep out of reach of children.

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

Directions

apply as needed

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Squalane, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Sunflower Seed Oil Polyglyceryl-3 Esters, Hydroxystearic/Linolenic/Oleic Polyglycerides, Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Ceramide NP, Tocopherol, Sodium Phytate, Hydrogenated Sunflower Seed Oil, Glyceryl Esters, Cetearyl Alcohol, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, Xanthan Gum, Ethylhexylglycerin, Potassium Sorbate, Citric Acid.

Questions or comments?

Call 855-747-2229

Package Labeling:73517-001-01

Add image transcription here...

Package Labeling:73517-001-06

INGREDIENTS AND APPEARANCE

PIPETTE ECZEMA

oatmeal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73517-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
CERAMIDE NP (UNII: 4370DF050B)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYTATE SODIUM (UNII: 88496G1ERL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73517-001-01	1 in 1 BOX	05/16/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:73517-001-06	1 in 1 BOX	05/16/2022
2		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/16/2022

Labeler - Amyris, Inc (185930182)

Revised: 6/2022

Document Id: e0c3c0da-7d86-12e2-e053-2a95a90afbe2

Set id: 5c5c81cd-6763-4c80-b1c6-89bbac703a8c

Version: 1

Effective Time: 20220606