Elizabeth Arden Eight Hour Cream Skin Protectant

Elizabeth Arden Eight Hour Cream Skin Protectant
SPL v3
SPL
SPL Set ID b590991c-8ec8-67c2-e053-2a95a90a3acf
Route
TOPICAL
Published
Effective Date 2016-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (56.8 mg)
Inactive Ingredients
Limonene, (+)- Linalool, (+/-)- Lanolin Mineral Oil Soybean Oil Ferric Oxide Red Butylated Hydroxytoluene Geraniol Corn Oil Phenoxyethanol Castor Oil Citral Caprylyl Glycol Salicylic Acid Tocopherol Ferric Oxide Yellow .beta.-citronellol, (r)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-16

Description

Petrolatum 56.8%................... Skin Protectant


Medication Information

Warnings and Precautions
  • For external use only
Indications and Usage

Uses

Treats symptoms of:

  • chapping
  • peeling or flaking due to minor burns
  • suncrun
  • windburn
  • scrapes
  • abrasions
  • cracked lips
Dosage and Administration
  • Apply liberally as often as necessary
Description

Petrolatum 56.8%................... Skin Protectant

Uses

Treats symptoms of:

■ chapping

■ peeling or flaking due to minor burns

■ sunburn

■ windburn

■ scrapes

■ abrasions

■ cracked lips

Section 50565-1

NA

Section 55105-1

Skin Protectant

Warnings

Warnings

■ For external use only



When using this product

■ Avoid contact with eyes

■ Do not apply over puncture wounds, infections or lacerations

Stop using and ask a doctor if

■ Symptoms persist more than 7 days

Carton Art

Directions

■ Apply liberally as often as necessary

Other Ingredients

LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, PARFUM/FRAGRANCE, RICINUS COMMUNIS (CASTOR) SEED OIL, SALICYLIC ACID, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492).

Active Ingredients

Petrolatum 56.8%................... Skin Protectant


Structured Label Content

Uses (USES)

Treats symptoms of:

■ chapping

■ peeling or flaking due to minor burns

■ sunburn

■ windburn

■ scrapes

■ abrasions

■ cracked lips

Indications and Usage (34067-9)

Uses

Treats symptoms of:

  • chapping
  • peeling or flaking due to minor burns
  • suncrun
  • windburn
  • scrapes
  • abrasions
  • cracked lips
Dosage and Administration (34068-7)
  • Apply liberally as often as necessary
Warnings and Precautions (34071-1)
  • For external use only
Section 50565-1 (50565-1)

NA

Section 55105-1 (55105-1)

Skin Protectant

Warnings (WARNINGS)

Warnings

■ For external use only



When using this product

■ Avoid contact with eyes

■ Do not apply over puncture wounds, infections or lacerations

Stop using and ask a doctor if

■ Symptoms persist more than 7 days

Carton Art (CARTON ART)

Directions (DIRECTIONS)

■ Apply liberally as often as necessary

Other Ingredients (OTHER INGREDIENTS)

LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, PARFUM/FRAGRANCE, RICINUS COMMUNIS (CASTOR) SEED OIL, SALICYLIC ACID, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492).

Active Ingredients (ACTIVE INGREDIENTS)

Petrolatum 56.8%................... Skin Protectant


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)