MEIJER SKIN RELIEVING MOISTURIZING- dimethicone lotion

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

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Active ingredient:
Dimethicone 1.2%
Available from:
MEIJER DISTRIBUTION, INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant - helps prevent and temporarily protects chafed, chapped or cracked skin - helps protect from the drying effects of wind and cold weather Do not use on - deep or puncture wounds - animal bites - serious burns
Authorization status:
OTC monograph final
Authorization number:
41250-985-43

MEIJER SKIN RELIEVING MOISTURIZING- dimethicone lotion

MEIJER DISTRIBUTION, INC

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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Meijer Skin Relieving Moisturizing Lotion

Meijer Skin Relieving Moisturizing Lotion - Drug Facts

Active ingredients

Dimethicone 1.2%

Purpos e

Skin Protectant

Us es

helps prevent and temporarily protects chafed, chapped or cracked skin

helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product do not get into eyes

Do not use on

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

condition worsens

symptoms last more than seven days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

apply as needed to hands or body when skin feels dry or irritated

Other Information may stain some fabrics

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa

(oat) kernel flour, benzyl alcohol, avena sativa (oat) kernel oil, steareth-20, avena sativa (oat) kernel

extract, butyrospermum parkii (shea) butter, potassium sorbate, sodium chloride

Meijer Skin Relieving Moisturizing Lotion

18 fl oz (532mL)

NDC 41250-990-43

MEIJER SKIN RELIEVING MOISTURIZING

dimethicone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -9 8 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

MEIJER DISTRIBUTION, INC

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

12 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

SHEA BUTTER (UNII: K49 155WL9 Y)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

O ATMEAL (UNII: 8 PI54V6 6 3Y)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PETRO LATUM (UNII: 4T6 H12BN9 U)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

O AT KERNEL O IL (UNII: 3UVP41R77R)

STEARETH-2 0 (UNII: L0 Q8 IK9 E0 8 )

O AT (UNII: Z6 J79 9 EAJK)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:41250 -9 8 5-

532 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/23/20 19

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 rt347

0 7/23/20 19

Labeler -

MEIJER DIST RIBUT ION, INC (006959555)

Registrant -

Fruit Of T he Earth, Inc. (079559467)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fruit Of The Earth Research Labo rato ries, Inc.

0 0 8 19 3513

ma nufa c ture (41250 -9 8 5)

Revised: 7/2019

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