Quality Choice Maximum Strength Zinc Oxide (Zinc Oxide) Ointment [Chain Drug Marketing Association Inc] -

QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE (ZINC OXIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC	63868-593-57
Set ID	975bf0fb-2832-486a-942e-d6ef83855881
Category	HUMAN OTC DRUG LABEL
Packager	Chain Drug Marketing Association Inc
Generic Name
Product Class
Product Number
Application Number	PART347

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Active ingredient

Zinc oxide 40%...........................Skin protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings

For external use only
When using this product
- do not get into eyes
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding

ask a health professional before use.
Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area, and allow to dry
- apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
Other information
- store at 20°-25°C (68°-77°F)
- may stain clothing
Inactive ingredients

.alpha.-tocopherol acetate, butylated hydroxytoluene, lanolin, lavender oil, light mineral oil, methylparaben, petrolatum, polysorbate 60
DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376

www.qualitychoice.com

Made in China
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE
zinc oxide ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LAVENDER OIL (UNII: ZBP1YXW0H8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-500-57	1 in 1 CARTON	11/11/2019
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/11/2019

Labeler - Chain Drug Marketing Association Inc (011920774)

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Medic