SUDOCREM SKIN PROTECTANT- zinc oxide cream

SUDOCREM SKIN PROTECTANT by

Drug Labeling and Warnings

SUDOCREM SKIN PROTECTANT by is a Otc medication manufactured, distributed, or labeled by LEDA INNOVATIONS USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc oxide (15.29%)

Purpose

Skin protectant

Uses

• Helps treat and prevent Diaper Rash and Incontinence Dermatitis
• Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness

Warnings

For external use only.

When using this product

• do not get into eyes

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

• Apply as needed
• For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

• Store at room temperature between 15C and 30C (59F to 86F)
• Do not use if safety seal is broken or missing

Inactive ingredients

beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, water

Product Packaging

INGREDIENTS AND APPEARANCE

SUDOCREM SKIN PROTECTANT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84589-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	152.9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)
LINALYL ACETATE (UNII: 5K47SSQ51G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
BENZYL BENZOATE (UNII: N863NB338G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
YELLOW WAX (UNII: 2ZA36H0S2V)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL ESTERS WAX (UNII: D072FFP9GU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84589-002-10	1 in 1 BLISTER PACK	08/06/2024
1		10 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 84589-002-60	60 g in 1 JAR; Type 0: Not a Combination Product	08/06/2024
3	NDC: 84589-002-12	125 g in 1 JAR; Type 0: Not a Combination Product	08/06/2024
4	NDC: 84589-002-25	250 g in 1 JAR; Type 0: Not a Combination Product	08/06/2024
5	NDC: 84589-002-40	400 g in 1 JAR; Type 0: Not a Combination Product	08/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/06/2024

Labeler - LEDA INNOVATIONS USA, INC. (779937036)