ECZEMA THERAPY- chamomile extract, tea tree oil, aloe extract soap

Eczema Therapy by

Drug Labeling and Warnings

Eczema Therapy by is a Otc medication manufactured, distributed, or labeled by Golden B America, LLC., Asan C&S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Chamomile Extract (0.3%)

Tea tree oil (0.2%)

Aloe Extract (0.12%)

Purpose

Anti-itchy

Anti-bacterial

Humectant

Uses

Helps to relieve skin irritation and itching due to eczema.

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
• do not apply directly to wound or open cut

Stop use and ask a doctor if

• rash or irritation on skin develops and lasts
• condition does not improve or worsen after regular use of this product as directed

Keep out reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

1. Wet soap to generate foam to cover desired part of face or body

2. Massage foam well into the skin rubbing gently.

3. Rinse after 3-5 min.

4. Pat dry with soft cloth, leaving bit of moisture.

5. Repeat 2-3 times daily as needed.

Inactive ingredients

Peanut Oil, Zinc Oxide, Shea Butter, Arginine, Grape Seed Oil, Gardenia Seed Extract, Green Tea Extract, Mugwort Extract, Licorice Root Extract, Shrubby Sophora Extract, Tocophenol, Pure Water, charcoal, Sekken Soji

Eczema Therapy Soap

INGREDIENTS AND APPEARANCE

ECZEMA THERAPY 
chamomile extract, tea tree oil, aloe extract soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72100-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	0.3 g  in 100 g
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	0.2 g  in 100 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	0.12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ZINC OXIDE (UNII: SOI2LOH54Z)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
LICORICE (UNII: 61ZBX54883)
TOCOPHEROL (UNII: R0ZB2556P8)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
ARGININE (UNII: 94ZLA3W45F)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
PEANUT OIL (UNII: 5TL50QU0W4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72100-101-02	1 in 1 PACKAGE	03/13/2018
1	NDC: 72100-101-01	100 g in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/13/2018

Labeler - Golden B America, LLC. (081015296)

Registrant - Golden B America, LLC. (081015296)

Establishment
Name	Address	ID/FEI	Business Operations
Golden B America, LLC.		081015296	relabel(72100-101)

Establishment
Name	Address	ID/FEI	Business Operations
Asan C&S		631139649	manufacture(72100-101)