NDC | 72100-101-01, 72100-101-02 |
Set ID | 6753865f-29be-0557-e053-2991aa0a96c7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Golden B America, LLC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Active ingredients
- Purpose
- Uses
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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
- Directions
- Inactive ingredients
- Eczema Therapy Soap
-
INGREDIENTS AND APPEARANCE
ECZEMA THERAPY
chamomile extract, tea tree oil, aloe extract soapProduct 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)