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NDC 63645-0169-06 OraLabs ChapIce Original Petrolatum 45 mg/g Details

OraLabs ChapIce Original Petrolatum 45 mg/g

OraLabs ChapIce Original Petrolatum is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is PETROLATUM.

Product Information

NDC	63645-0169
Product ID	63645-169_733a76a9-2460-472e-8b5c-93008351509f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	OraLabs ChapIce Original Petrolatum
Proprietary Name Suffix	n/a
Non-Proprietary Name	Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	45
Active Ingredient Units	mg/g
Substance Name	PETROLATUM
Labeler Name	OraLabs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63645-0169-06 (63645016906)

Pricing Information	N/A
NDC Package Code	63645-169-06
Billing NDC	63645016906
Package	1 g in 1 CONTAINER (63645-169-06)
Marketing Start Date	2020-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 54729693-f0e2-48ad-881a-a07986ed823b Details

Active ingredient

Petrolatum, 45%

Purpose

Skin Protectant

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Helps prevent and temporarily protect dry, chapped or windburned lips.

Warnings

For external use only. Stop use and ask a doctor if rash or irritation develops and lasts. Children under 6 months of age: Ask a doctor before use.

Directions

Apply as needed.

Inactive Ingredients

Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ORALABS CHAPICE ORIGINAL PETROLATUM

petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-169
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	45 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)	28 ug in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	17.5 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	3.0 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)	1.0 mg in 1 g

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-169-06	1 g in 1 CONTAINER; Type 0: Not a Combination Product	03/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/09/2020

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-169) , LABEL(63645-169)

Revised: 1/2022

Document Id: 733a76a9-2460-472e-8b5c-93008351509f

Set id: 54729693-f0e2-48ad-881a-a07986ed823b

Version: 2

Effective Time: 20220121