SKIN PROTECTANT CREAM 43% PETROLATUM- 43% petrolaum skin protectant cream

Skin Protectant Cream 43% Petrolatum by

Drug Labeling and Warnings

Skin Protectant Cream 43% Petrolatum by is a Otc medication manufactured, distributed, or labeled by Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only. Avoid contact with the eyes. Stop use and ask physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Do not use on deep or puncture wounds, animal bites or serious burns.

Uses

For the temporary protection of: diaper rash, minor: cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin. Helps protect from drying effects of wind and cold weather.

DOSAGE & ADMINISTRATION

Keep out of reach of children

Keep out of reach of children

Active Ingredients

Petrolatum 43%   Skin Protectant

PURPOSE

Inactive Ingredients

Purified Water, Hydroxylated Lanolin, PEG-30 Dipolyhydroxystearate, Sorbitan Sesquioleate, Mineral Oil, Glycerin, Steareth-20, Ozokerite Wax, Magnesium Sulfate, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate

Labeling

INGREDIENTS AND APPEARANCE

SKIN PROTECTANT CREAM 43% PETROLATUM 
43% petrolaum skin protectant cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60232-0021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	43 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
STEARETH-20 (UNII: L0Q8IK9E08)
CERESIN (UNII: Q1LS2UJO3A)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROXYLATED LANOLIN (UNII: EOI0B9800C)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60232-0021-4	118 g in 1 TUBE; Type 0: Not a Combination Product	09/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/02/2013

Labeler - Swiss-American CDMO, LLC (080170933)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(60232-0021)