EA EIGHT HOUR SKIN PROTECTANT- petrolatum emulsion

EA EIGHT HOUR SKIN PROTECTANT by

Drug Labeling and Warnings

EA EIGHT HOUR SKIN PROTECTANT by is a Otc medication manufactured, distributed, or labeled by REVLON, Englewood Lab. INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

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

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).

USES

Treats symptoms of:
■ chapping

■ peeling or flaking due to minor burns

■ sunburn
■ windburn

■ scrapes

■ abrasions
■ cracked lips

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

DIRECTIONS

■ Apply liberally as often as necessary

DOSAGE & ADMINISTRATION

• Apply liberally as often as necessary

WARNINGS

• For external use only

INDICATIONS & USAGE

Uses

Treats symptoms of:

• chapping
• peeling or flaking due to minor burns
• suncrun
• windburn
• scrapes
• abrasions
• cracked lips

KEEP OUT OF REACH OF CHILDREN

NA

PURPOSE

Skin Protectant

CARTON ART

CARTON ART

INGREDIENTS AND APPEARANCE

EA EIGHT HOUR SKIN PROTECTANT 
petrolatum emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-672
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	56.8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
SOYBEAN OIL (UNII: 241ATL177A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GERANIOL (UNII: L837108USY)
CORN OIL (UNII: 8470G57WFM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CASTOR OIL (UNII: D5340Y2I9G)
CITRAL (UNII: T7EU0O9VPP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SALICYLIC ACID (UNII: O414PZ4LPZ)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-672-17	50 g in 1 TUBE; Type 0: Not a Combination Product	02/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/16/2016

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
BEAUTYGE S.L.		472062523	manufacture(10967-672)