Soothing Incontinence Spray

DR. BUTLER SOOTHING INCONTINENCE- petrolatum 36% spray
Beyond Health P.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Petrolatum 36%

Skin Protectant

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

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.

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

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

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.

Label

DR. BUTLER SOOTHING INCONTINENCE
petrolatum 36% spray

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Beyond Health P.A. (026781064)

Registrant - Derma Care Research Labs (116817470)

Name	Address	ID/FEI	Business Operations
Establishment
Derma Care Research Labs		116817470	manufacture(70942-017)