BABY BALM STICK 0.65OZ- petrolatum ointment ointment

Baby Balm Stick 0.65oz by

Drug Labeling and Warnings

Baby Balm Stick 0.65oz by is a Otc medication manufactured, distributed, or labeled by China Ningbo Shangge Cosmetics Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Petrolatun 30%

Purpose

Skin Protectant (Ointment)

Use

temporarily protects minor;
cut
scrapes
burns
temporarily protects and helps relieve chapped or cracked skin and lips
helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

When using this product do not get into eyes.

Stop use and ask a doctor if

condition worsens
symptoms last more than 7days or clear up and occur again within a few days.

Do not use on

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

Inactive ingredients

Mineral Oil
polyisobutene
polyisobutene
beeswax
microcrystalline wax
butyrospermum parkii (shea butter) oil
BHT
Bisabolol
Glycerin
Tocopherol
Panthenol

Other information

For best product quality, store below 113°F/45°C.

label

INGREDIENTS AND APPEARANCE

BABY BALM STICK 0.65OZ 
petrolatum ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58503-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PANTHENOL (UNII: WV9CM0O67Z)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
SHEANUT OIL (UNII: O88E196QRF)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58503-203-01	18.4 g in 1 TUBE; Type 0: Not a Combination Product	08/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/29/2024

Labeler - China Ningbo Shangge Cosmetics Technology Corp. (529287434)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetics Technology Corp.		529287434	manufacture(58503-203)