GZE NIPPLE BALM (butyrospermum parkii- shea butter paste

GZE NIPPLE BALM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

OLEA EUROPAEA (OLIVE) FRUIT OIL

INACTIVE INGREDIENT

BEESWAX

TOCOPHEROL

BISABOLOL

AROMA

PURPOSE

Moisturising.

INDICATIONS & USAGE

Use anytime on sore, cracked nursing nipples to soften and smooth the skin.
It can also be used to moisturize lips, heels, elbows and other areas.

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

Take a coin-sized amount of cream, apply to desired area and massage until absorbed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE NIPPLE BALM 
butyrospermum parkii (shea butter) paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y)	SHEA BUTTER	58.73 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L)	COCONUT OIL	12.36 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E)	OLIVE OIL	8.46 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.BETA.-BISABOLOL (UNII: LP618AV2EA)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)
AROMADENDRIN (UNII: 7YA4640575)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-048-01	60 g in 1 JAR; Type 0: Not a Combination Product	06/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/23/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co., Ltd		712647107	manufacture(83566-048)