ECZEMA THERAPY- chamomile extract, tea tree oil, aloe extract soap 
Golden B America, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Eczema Therapy Soap

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

Stop use and ask a doctor if

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

eczema soap

ECZEMA THERAPY 
chamomile extract, tea tree oil, aloe extract soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72100-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE0.3 g  in 100 g
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.2 g  in 100 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE0.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72100-101-021 in 1 PACKAGE03/13/2018
1NDC:72100-101-01100 g in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/13/2018
Labeler - Golden B America, LLC. (081015296)
Registrant - Golden B America, LLC. (081015296)
Establishment
NameAddressID/FEIBusiness Operations
Golden B America, LLC.081015296relabel(72100-101)
Establishment
NameAddressID/FEIBusiness Operations
Asan C&S631139649manufacture(72100-101)

Revised: 3/2018
Document Id: 6753865f-29bf-0557-e053-2991aa0a96c7
Set id: 6753865f-29be-0557-e053-2991aa0a96c7
Version: 2
Effective Time: 20180313
 
Golden B America, LLC.