ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT: Package Insert and Label Information

ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT- petrolatum gel
ELIZABETH ARDEN, INC

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.

Active Ingredient

Petrolatum 85%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve
• chapping
• peeling or flaking due to minor sunburn
• windburn
• cracked lips

Directions

• Apply liberally as often as necessary

Inactive Ingredients

LANOLIN, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, BIS-DIGLYCERYL POLYACYLADIPATE-2, LANOLIN OIL, PARFUM/FRAGRANCE, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, IRON OXIDES (CI 77499), TITANIUM DIOXIDE (CI 77891), YELLOW 5 LAKE (CI 19140), YELLOW 6 LAKE (CI 15985).

Questions or comments?

Call toll free 1-800 326-7337

Principal Display Panel — Eight Hour Lip Protectant Carton Label

ElizabethArden

NEW YORK

AROUND
WITH 8 HOUR
THE WORLD

Take Off
and Touch Down

Lip Duo

Lip Scrub

Lip Protectant

NET WT. .45 OZ. 13g EACH

ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT petrolatum gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-3052 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (PETROLATUM) PETROLATUM 1 g in 85 g

Inactive Ingredients Ingredient Name Strength LANOLIN CARNAUBA WAX LANOLIN OIL CITRAL .BETA.-CITRONELLOL, (R)- GERANIOL LINALOOL, (+/-)- FERROSOFERRIC OXIDE TITANIUM DIOXIDE FD&C YELLOW NO. 5 FD&C YELLOW NO. 6

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67938-3052-1 1 CANISTER in 1 CARTON contains a CANISTER 1 13 g in 1 CANISTER This package is contained within the CARTON (67938-3052-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/01/2017

Labeler — ELIZABETH ARDEN, INC (849222187)

Revised: 08/2017 ELIZABETH ARDEN, INC