DR. SELBY CURATIVE DIAPER RASH AND SKIN PROTECTANT- zinc oxide ointment
Tactical Products International, LLC

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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Dr. Selby Curative Diaper Rash and Skin Protectant

Drug Facts

Active ingredient

Zinc Oxide 6.5%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash.
Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

For external use only

When using this product

Do not get into 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, get medical help or contact Poison Control Center right away.

Directions

Change wet and soiled diapers promptly.
Cleanse the diaper area and allow to dry.
Apply ointment 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 59 o -86 oF (15 o -30 oC)

Inactive ingredients

boric acid, lanolin, light mineral oil, petrolatum, talc, vitamin D, water

Terry S.A.

Made by: Terry S.A. Rivera 3270 Montevideo, Uruguay. Ind. Uruguaya Distributed by: Tactical Products International, LLC 2400 Crownpoint Executive Dr., Suite 300 Charlotte, North Carolina, 28227 USA 1 (844) DrSelby (1-844-377-3529)A Made in Uruguay

Dr. Selby Curative Diaper Rash Ointment and Skin Protectant Zinc Oxide 6.5% Protects Chafed Skin And Minor Skin Irritation Due To Diaper Rash Must Have in the Medicine Cabinet! Net Wt. 1.4 oz (40 g) Net Wt. 0.18 oz (5g)

Product Labels

TerrySA1 TerrySA2

TerrySA05

DR. SELBY CURATIVE DIAPER RASH AND SKIN PROTECTANT
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69342-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	65 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
VITAMIN D (UNII: 9VU1KI44GP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69342-001-40	1 in 1 CARTON	10/30/2014	01/01/2018
1		40 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69342-001-05	1 in 1 CARTON	10/30/2014	01/01/2018
2		5 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/30/2014	01/01/2018

Labeler - Tactical Products International, LLC (079388183)

Revised: 1/2018

Document Id: 61d32bb5-da77-0caf-e053-2a91aa0ad20d

Set id: f895da8f-e518-43f7-a013-3dd24feb470f

Version: 4

Effective Time: 20180102

Tactical Products International, LLC