CHAP-ET- white petrolatum lipstick

Chap-et by

Drug Labeling and Warnings

Chap-et by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts - Regular

Active ingredient

White petrolatum 61.93%

Purpose

Skin protectant

Use

• helps prevent, temporarily protects and helps relieve chafed, chapped or cracked lips
  
• helps prevent and protect lips from the drying effects of wind and cold weather

Warnings

• 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 more than used for lip protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed

Other information

store at room temperature

Inactive ingredients

camphor, hydrogenated vegetable oil, iron oxides, isopropyl myristate, lecithin, mineral oil, wax

Questions?

call toll-free 1-866-255-5202 weekdays

Drug Facts - Cherry

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavors, red 27 lake, lecithin, hydrogenated vegetable oil

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

Drug Facts – Bubble Gum

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavors, saccharin, red 27 lake, lecithin, hydrogenated vegetable oil

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

Drug Facts – Mint

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavor, blue 2 lake, yellow 10 lake, blue 1 lake, lecithin, hydrogenated vegetable oil, saccharin

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

Drug Facts – Vanilla

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavor, saccharin, iron oxides, yellow 10 lake, lecithin, hydrogenated vegetable oil

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

PRINCIPAL DISPLAY PANEL

Regular chap-et
LIP BALM SKIN PROTECTANT
NET WT .16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL

Cherry chap-et
LIP BALM SKIN PROTECTANT
NET WT .16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL

Bubble Gum chap-et
LIP BALM SKIN PROTECTANT
NET WT .16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL

Mint chap-et
LIP BALM SKIN PROTECTANT
NET WT .16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL

Vanilla chap-et
LIP BALM SKIN PROTECTANT
NET WT .16 OZ (4.5g)

INGREDIENTS AND APPEARANCE

CHAP-ET 
white petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-411
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	619.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CORN OIL (UNII: 8470G57WFM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-411-01	1 in 1 CARTON	06/01/2012
1		4.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/2012

CHAP-ET 
white petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-422
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	619.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)
CORN OIL (UNII: 8470G57WFM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-422-02	4.5 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/2012

CHAP-ET 
white petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	619.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)
CORN OIL (UNII: 8470G57WFM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SACCHARIN (UNII: FST467XS7D)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-444-02	4.5 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/2012

CHAP-ET 
white petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-433
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	619.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CORN OIL (UNII: 8470G57WFM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SACCHARIN (UNII: FST467XS7D)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-433-01	4.5 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/2012

CHAP-ET 
white petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	619.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CORN OIL (UNII: 8470G57WFM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SACCHARIN (UNII: FST467XS7D)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-455-01	4.5 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/2012

Labeler - Medtech Products Inc. (122715688)