EA EIGHT HOUR SKIN PROTECTANT- petrolatum emulsion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Petrolatum 56.8%................... Skin Protectant
Available from:
REVLON
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Treats symptoms of: ■ chapping ■ peeling or flaking due to minor burns ■ sunburn ■ windburn ■ scrapes ■ abrasions ■ cracked lips
Authorization status:
OTC monograph final
Authorization number:
10967-672-17

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EA EIGHT HOUR SKIN PROTECTANT- petrolatum emulsion

REVLON

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.

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ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT

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

CARTON ART

CARTON ART

EA EIGHT HOUR SKIN PROTECTANT

petrolatum emulsion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 9 6 7-6 72

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

REVLON

Ingredient Name

Basis of Strength

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

56 .8 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CITRAL (UNII: T7EU0 O9 VPP)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

MINERAL O IL (UNII: T5L8 T28 FGP)

SO YBEAN O IL (UNII: 241ATL177A)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

GERANIO L (UNII: L8 3710 8 USY)

CO RN O IL (UNII: 8 470 G57WFM)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CASTO R O IL (UNII: D5340 Y2I9 G)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

SALICYLIC ACID (UNII: O414PZ4LPZ)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

LANO LIN (UNII: 7EV6 5EAW6 H)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 9 6 7-6 72-17

50 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 2/16 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 2/16 /20 16

Labeler -

REVLON (788820165)

Registrant -

REVLON (788820165)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Englewo o d Lab. INC.

0 8 0 9 8 7545

ma nufa c ture (10 9 6 7-6 72)

Revised: 12/2020

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