DR. BUTLER SOOTHING INCONTINENCE- petrolatum 36% spray

Dr. Butler Soothing Incontinence by

Drug Labeling and Warnings

Dr. Butler Soothing Incontinence 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

Petrolatum 36%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Temporarily protects and helps relieve chafed, chapped, or cracked skin.

WARNINGS

For external use only.

Do not use on deep or puncture wounds.

When using this product avoid contact in eyes, rinse with water to remove, contents under pressure, do not puncture or incinerate, do not store at temperatures above 120F.

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.

Ask a healthcare or professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed.

INACTIVE INGREDIENT

4-t-Butylcyclohexanol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Mineral Oil, Pentylene Glycol, PPG-15 Stearyl Ether.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. BUTLER SOOTHING INCONTINENCE 
petrolatum 36% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	59.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
ALOE (UNII: V5VD430YW9)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CHAMOMILE (UNII: FGL3685T2X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-017-03	85 g in 1 CAN; Type 0: Not a Combination Product	07/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/26/2021

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(70942-017)