GZE AFRICAN BLACKSOAP (butyrospermum parkii- shea butter soap

GZE African BlackSoap by

Drug Labeling and Warnings

GZE African BlackSoap by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yilong Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Cleaning skin.

INDICATIONS & USAGE

Cut a smaller bar size piece for use. Lather with a sponge,wash cloth, loofah, or similar device after getting it wet. Applto any part of the body you want cleaned. Rinse & Repeat asdesired.

WARNINGS

For external use only.

STOP USE

Stop use and ask a doctor if rash occurs.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

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

Cut a smaller bar size piece for use. Lather with a spongewash cloth, loofah, or similar device after getting it wet. Applto any part of the body you want cleaned. Rinse & Repeat asdesired.

ACTIVE INGREDIENT

BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES

INACTIVE INGREDIENT

Water

Elaeis Guineensis (Palm) Kernel Oil

Cocos Nucifera(Coconut) Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE AFRICAN BLACKSOAP 
butyrospermum parkii (shea) butter soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) (BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES - UNII:0C9AC7D6XU)	BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
ELAEIS GUINEENSIS FRUIT BUTTER (UNII: UYH3R74N56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-049-01	100 g in 1 BAG; Type 0: Not a Combination Product	12/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/22/2023

Labeler - Guangzhou Yilong Cosmetics Co., Ltd (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co., Ltd		712647107	manufacture(83566-049)