DR BUTLER DIAPER RASH- dimethicone 1% cream

Dr Butler Diaper Rash by

Drug Labeling and Warnings

Dr Butler Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Beyond Health P.A., Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dimethicone 1%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Helps treat and prevent diaper rash, protects minor skin irritation due to diaper rash and helps seal out wetness.

WARNINGS

For external use only.

Do not use on deep or puncture wounds, animal bites, or serious burns.

When using this product avoid contact with eyes.

Stop use and ask a doctor 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 swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Change wet and soiled diapers promptly, cleanse the diaper area, and allow 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.

INACTIVE INGREDIENT

Water, glycerin, petrolatum, panthenol, stearyl alcohol, steareth-20, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel oil, sodium hyaluronate, hamamelis virginiana (witch hzael) leaf extract, rosmarinus officinalis (rosemary) leaf extract, claendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, curcuma longa (tumeric) root extract, olea europaea (olive) leaf extract, lavandula angustifolia (lavender) flower extract, helichrysum italicum extract, centella asiatica extract, panax ginseng root extract, aesculus hippocastanum (horse chestnut) extract, melaleuca alternifolia (tea tree) leaf extract, carya ovata bark extract, avena sativa (oat) kernel extract, cucumis sativus (cucumber) fruit extract, sorbitol, lecithin, xanthan gum, oleic acid, iron oxides (CI 77491), phenoxyethanol, ethylhexylglycerin, sodium chloride, colloidal oatmeal, 4-t-butylcyclohexanol, pentylene glycol, benzalkonium chloride, ceramide NP.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR BUTLER DIAPER RASH 
dimethicone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE 350 (UNII: 2Y53S6ATLU) (DIMETHICONE 350 - UNII:2Y53S6ATLU)	DIMETHICONE 350	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITOL (UNII: 506T60A25R)
CARYA OVATA BARK (UNII: X765CF609L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OATMEAL (UNII: 8PI54V663Y)
CUCUMBER (UNII: YY7C30VXJT)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CHAMOMILE (UNII: FGL3685T2X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STEARETH-20 (UNII: L0Q8IK9E08)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
ROSEMARY (UNII: IJ67X351P9)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
OAT KERNEL OIL (UNII: 3UVP41R77R)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ASIAN GINSENG (UNII: CUQ3A77YXI)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7)
CERAMIDE NP (UNII: 4370DF050B)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
OLEIC ACID (UNII: 2UMI9U37CP)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-259-03	85 g in 1 CAN; Type 0: Not a Combination Product	03/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	03/22/2023

Labeler - Beyond Health P.A. (026781064)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(70942-259)