Drug Facts

Active Ingredient (in percentage)

Hydrocortisone 0.5%

Purpose

For relief of minor skin irritation.

USES:

Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

WARNINGS:

For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat.

Keep out of reach of children.

DIRECTIONS:

Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

INACTIVE INGREDIENTS:

Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.

Package Labeling:

Label

PETROCORT ANTIPRURITIC LIP 21
hydrocortisone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51822-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.005 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
PADIMATE O (UNII: Z11006CMUZ)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51822-021-15	4.25 g in 1 TUBE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	12/26/2017

Labeler - Clinical Formula LLC (084120658)

Name	Address	ID/FEI	Business Operations
Establishment
Clinical Formula LLC		084120658	manufacture(51822-021)

Petrocort Antipruritic Lip Balm #21