QUALITY CHOICE CALAMINE- calamine 8% and zinc oxide 8% lotion

Chain Drug Market As s ociation

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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Quality Choice Calamine Lotion, USP

Drug Facts

Active Ingredients
Calamine 8% and Zinc Oxide 8%

Purpos e
Skin protectant

Us es
dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Warnings
For external use only. Use only as directed.
Avoid contact with eyes and mucous membranes.
Ask a doctor before using on chilren 6 months of age.

When us ing this product

Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control center
immediately.

Directions
Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and
water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as
often as needed for comfort.
Children under 6 months of age: Consult a doctor before use.

Other information
Store at room temperature 13-30C (50-86F)

Inactive ingredients
Bentonite magma, calcium hydroxide, glycerin, purified water.

Package Principal Dis play Panel

QUALITY CHOICE CALAMINE

calamine 8% and zinc oxide 8% lotion

Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:6 38 6 8 -317

Route of Ad minis tration TO PICAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th
ZINC O XIDE (UNII: SO I2LO H54Z) (ZINC CATIO N - UNII:13S1S8 SF37) ZINC CATIO N 16 0 mg in 1 mL

Inactive Ing redients

Ing redient Name Streng th
CALCIUM HYDRO XIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6 A3C0 O X)
WATER (UNII: 0 59 Q F0 KO 0 R)

Packag ing
Marketing Start Marketing End
 Marketing Start Marketing End
# Item Co de Packag e Descriptio n
Date Date
NDC:6 38 6 8 -317- 177 mL in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n
1 12/12/20 17
06 Pro duc t

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
O TC mo no gra ph fina l pa rt347 0 3/25/19 9 8

Labeler - Chain Drug Market As s ociation (011920774)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
Humc o Ho lding Gro up, la be l(6 38 6 8 -317) , ma nufa c ture (6 38 6 8 -317) , a na lysis(6 38 6 8 -317) , pa c k(6 38 6 8 -
8 256 728 8 4
Inc . 317)

Revised: 6/2020 Chain Drug Market Association