GLINT EN SHIELD ALOE SOFT VITAMIN ENRICHED- zinc oxide cream

GLINT by

Drug Labeling and Warnings

GLINT by is a Otc medication manufactured, distributed, or labeled by GLINT COSMETICS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide (3.8%w/w)

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When using this product

■ do not get into eyes

Stop Use and ask a doctor if

conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children

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

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive ingredients

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender

methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium

steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

Package Label

INGREDIENTS AND APPEARANCE

GLINT  EN SHIELD ALOE SOFT VITAMIN ENRICHED
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71486-3066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CETETH-10 (UNII: LF9X1PN3XJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
STEARETH-20 (UNII: L0Q8IK9E08)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A (UNII: 81G40H8B0T)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71486-3066-4	99.2 g in 1 TUBE; Type 0: Not a Combination Product	09/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/19/2018

Labeler - GLINT COSMETICS PRIVATE LIMITED (675910492)