Eczema by Amyris, Inc Pipette Eczema Lotion

Eczema by

Drug Labeling and Warnings

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

Drug Details [pdf]

ECZEMA- colloidal oatmeal lotion 
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

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 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

•   Apply as needed

Other information

Protect this product from excessive heat and direct sunlight

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.
Cetearyl Alcohol, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, Xanthan
Gum, Citric Acid, Ethylhexylglycerin, Potassium Sorbate, Ceramide NP, Sodium Phytate, Tocopherol.

ECZEMA 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73517-425
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CERAMIDE NP (UNII: 4370DF050B)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73517-425-01	1 in 1 CARTON	02/01/2021
1		177 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73517-425-02	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: ec9769f6-68e7-7c92-e053-2a95a90a0bf6

34390-5

Set id: 25bd4368-0cb5-4396-8f26-ac0dac8e1be2

Version: 7

Effective Time: 20221103