PIPETTE ECZEMA- oatmeal liquid
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 Eczema Lotion

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

Outer Package

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Inner Package

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Package Labeling:73517-001-06

Outer Package2 Inner Package2

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	Marketing End 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

Amyris, Inc