GZE NIPPLE BALM by Guangzhou Yilong Cosmetics Co., Ltd GZE NIPPLE BALM

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]

GZE NIPPLE BALM- butyrospermum parkii (shea butter) paste 
Guangzhou Yilong Cosmetics Co., Ltd

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GZE NIPPLE BALM

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

OLEA EUROPAEA (OLIVE) FRUIT OIL

BEESWAX

TOCOPHEROL

BISABOLOL

AROMA

Moisturising.

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.

For external use only.

Stop use and ask a doctor if rash occurs.

Do not use on damaged or broken skin.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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
OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E)	OLIVE OIL	8.46 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L)	COCONUT OIL	12.36 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	07/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/23/2023	07/15/2025

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

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

Revised: 7/2025

Document Id: 39f4ae27-8c23-adaf-e063-6294a90a3ad3

34390-5

Set id: 1b26fd17-9ba6-6e66-e063-6294a90a5d6e

Version: 2

Effective Time: 20250715