RENEW INTENSIVE SKIN THERAPY TARGETED ECZEMA TREATMENT- colloidal oatmeal cream

Renew Intensive Skin Therapy by

Drug Labeling and Warnings

Renew Intensive Skin Therapy by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Colloidal oatmeal 1%

Purpose

Skin protectant

INDICATIONS & USAGE

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

• rashes
• eczema

Warnings

For external use only

WHEN USING

When using this product avoid contact with eyes

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• apply as needed or as directed by a doctor
• for children under 2 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• for mild to moderate eczema
• store below 86 F (30 C)

INACTIVE INGREDIENT

water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RENEW INTENSIVE SKIN THERAPY  TARGETED ECZEMA TREATMENT
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALLANTOIN (UNII: 344S277G0Z)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-410-01	50 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2024

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (079711683)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc.		079711683	manufacture(54473-410)