BABY BALM STICK 0.65OZ- petrolatum 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 Rejoice International Corp., 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-167
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
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEANUT OIL (UNII: O88E196QRF)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
CERESIN (UNII: Q1LS2UJO3A)
LEVOMENOL (UNII: 24WE03BX2T)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-167-01	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 - Rejoice International Corp. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetics Technology Corp.		529287434	manufacture(57337-167)