EQUATE CHERRY LIP BALM- petrolatum stick

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

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Active ingredient:
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Available from:
Walmart
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant Helps prevent and temporarily protects dry, chapped, or wind burned lips.
Authorization status:
OTC monograph final
Authorization number:
49035-671-01

EQUATE CHERRY LIP BALM- petrolatum stick

Walmart

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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Drug Facts

Active ingredient

White Petrolatum

Purpos e

Skin Protectant

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Us es

Helps prevent and temporarily protects dry, chapped, or wind burned lips.

Warnings

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally and as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone,

Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol,

Camphor, Red 6 Lake (CI 15850)

Package/Label Principal Display Panel

EQUATE CHERRY LIP BALM

petrolatum stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-6 71

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

PETROLATUM

45.0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

25.0 mg in 1 g

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

3.0 0 mg in 1 g

LANO LIN (UNII: 7EV6 5EAW6 H)

1 mg in 1 g

CERESIN (UNII: Q1LS2UJO3A)

17.50 mg in 1 g

CARNAUBA WAX (UNII: R12CBM0 EIZ)

1 mg in 1 g

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

2.33 mg in 1 g

Product Characteristics

Color

PINK

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-6 71-0 1

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

0 3/25/20 19

Walmart

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 3/25/20 19

Labeler -

Walmart (051957769)

Registrant -

OraLabs (801824756)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

O ra La bs

8 0 18 24756

MANUFACTURE(49 0 35-6 71) , LABEL(49 0 35-6 71)

Revised: 3/2019

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